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Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer
Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Protocol IDs
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Phase III, Phase II
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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OXC4T4-302 NCT00507429
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Trial Description
Summary The purpose of the study is to determine the safety and efficacy of combretastatin combined with paclitaxel and carboplatin in the treatment of anaplastic thyroid cancer (ATC). Further Study Information Anaplastic thyroid carcinoma (ATC) is a high-grade neoplasm, characterized by an aggressive clinical course with brief survival, and refractoriness to currently available local and systemic modalities of treatment. There is no standard therapy for ATC, and no randomized comparative trials have been known to be conducted in this disease. One potential strategy is to combine the anti-tumor activity of the vascular disrupting agent combretastatin with conventional cytotoxic agents. This study will compare the overall survival of ATC patients treated with the triplet combination of combretastatin, paclitaxel, and carboplatin compared with the doublet treatment of paclitaxel and carboplatin. Eligibility Criteria Inclusion Criteria: - Patients must have anaplastic thyroid carcinoma histologically or cytologically confirmed by a pathology review.
- Patients may have been refractory to or progressed during or after therapy, or relapsed within 6 months following initial combined modality therapy (usually including systemic chemotherapy and radiation) for regionally advanced disease.
- Where patients have received combined modality therapy for metastatic disease, systemic therapy is limited to one chemotherapy regimen that is clearly administered contiguously, (i.e., in an uninterrupted primary therapeutic approach). Patients who receive chemotherapy for metastatic disease after a combined modality approach are ineligible.
- In patients having received prior radiation, 4 weeks must have elapsed since radiation and disease must be present beyond radiation ports.
- A minimum of 3 weeks must have elapsed from the time a patient last received chemotherapy prior to the first dose of study drug (6 weeks for therapy known to be associated with delayed toxicity such as nitrosureas or mitomycin-C).
- Patients with bulky thyroid/neck masses and/or suspicion of airway obstruction must undergo screening (indirect and direct laryngoscopy) to ensure patency of the trachea/airway prior to study enrollment and treatment.
- Patients must be greater than or equal to 18 years of age.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Score less than or equal to 2.
- Life expectancy greater than or equal to 12 weeks.
- Patients must have adequate bone marrow reserve as evidenced by:
Absolute neutrophil count (ANC) greater than 1,500/microL. Platelet count greater than 75,000/microL. - Patients must have adequate renal function as evidenced by serum creatinine less than or equal to 2.0 mg/dL (less than 177 micromol/L).
- Patients must have adequate hepatic function as evidenced by:
Serum total bilirubin less than 2X greater than the upper limit of normal (ULN) (less than3X ULN in patients with liver metastases). AST (aspartate aminotransferase)/ALT (alanine aminotransferase) less than or equal to 3X the ULN for the local reference lab (less than or equal to 5X the ULN for patients with liver metastases). - Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
- Patients must have no clinically important sequelae from any prior surgery or radiotherapy.
- All women of childbearing potential must have a negative serum pregnancy test.
- Women of childbearing potential as well as fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication. (An effective form of contraception is an oral contraceptive or a double barrier method.)
Exclusion Criteria: - Patients with tumors confined to the thyroid.
- Patients with an uncontrolled active infection.
- Clinically evident brain metastasis, including symptomatic involvement, evidence of cerebral edema by CT or MRI, radiographic evidence of progression of brain metastasis since definitive therapy, or continued requirement for corticosteroids.
- Patients who receive chemotherapy for metastatic disease after completion of a combined modality approach.
- Patients with history of malignancies other than ATC except patients with curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of less than 4.0 mg/dL or microg/L. (Patients with other curatively treated malignancies who have no evidence of metastatic disease will be considered after discussion with the Medical Monitor.)
- Patients with known hypersensitivity to CA4P, paclitaxel or carboplatin, or any of their components.
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy for any indication within 28 days of the first scheduled day of dosing. (Investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication.)
- Patients with greater than Grade 2 peripheral neuropathy.
- Patients who are pregnant or lactating.
- Patients with a history of prior cerebrovascular event, including transient ischemic attack.
- Patients with uncontrolled hypertension defined as blood pressure greater than 150/100 mm Hg despite medication.
- Patients with symptomatic vascular disease (e.g. intermittent claudication)
- Patients with a history of unstable angina pectoris pattern, myocardial infarction (including non-Q wave MI) within the past 6 months, or NYHA Class III and IV congestive heart failure.
- Patients with a history of torsade de pointes.
- Patients with bradycardia (less than 60 b/m), heart block (excluding 1st degree block, being PR interval prolongation only), and congenital long QT syndrome.
- Patients with any ventricular arrhythmias, or new ST segment elevation or depression or Q wave on ECG.
- Patients with ejection fractions less than normal (i.e. less than 45%).
- Patients with QTc prolongation greater than 450 ms.
- Patients requiring any drugs known to prolong the QTc interval, including anti-arrhythmic medications.
- Patients with potassium concentrations below 4.0 mEq/dL and magnesium concentrations below 1.8 mg/dL despite being on an electrolyte supplement.
- Patients requiring any drugs known to prolong the QTc interval.
- Patients with any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- Patients with a history of solid organ transplant or bone marrow transplant.
Trial Contact Information
Trial Lead Organizations/Sponsors Oxigene, Incorporated Trial Sites
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U.S.A. |
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California |
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Los Angeles |
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| | | | | | | USC/Norris Comprehensive Cancer Center and Hospital |
| | Gina Tse |
Ph: 323-865-0514 |
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Email:
tse_g@ccnt.hsc.usc.edu |
| | Charlean Ketchens |
Ph: 323-226-2452 |
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Email:
ketchens_c@ccnt.hsc.usc.edu |
| | Barbara Gitlitz, MD | Principal Investigator |
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Colorado |
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Aurora |
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| | | University of Colorado Cancer Center at UC Health Sciences Center |
| | Brittany Hines |
Ph: 720-848-0634 |
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Email:
brittany.hines@uchsc.edu |
| | Bryan Haugen, MD | Principal Investigator |
| | Madeleine A Kane, MD, PhD | Sub-Investigator |
| | Joshua Klopper, MD | Sub-Investigator |
| | Julie Candia, NP | Sub-Investigator |
| | Sherif Said, MD, PhD | Sub-Investigator |
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Connecticut |
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New Haven |
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| | | Yale Cancer Center |
| | Janice Napoletano |
Ph: 203-785-7562 |
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Email:
janice.napoletano@yale.edu |
| | Julie A. Sosa, MD | Principal Investigator |
| | Hari Deshpande, MD | Sub-Investigator |
| | Scott Gettinger, MD | Sub-Investigator |
| | Sanziana Roman, MD | Sub-Investigator |
| | Robert Udelsman, MD | Sub-Investigator |
| | Gary Israel, MD | Sub-Investigator |
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Georgia |
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Atlanta |
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| | | Winship Cancer Institute of Emory University |
| | Austin Hamilton |
Ph: 404-778-4151 |
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Email:
austin.hamilton@emoryhealthcare.org |
| | Fadlo R Khuri, MD | Principal Investigator |
| | Nabil Saba, MD | Sub-Investigator |
| | Dong Shin, MD | Sub-Investigator |
| | Collin Weber, MD | Sub-Investigator |
| | William Grist, MD | Sub-Investigator |
| | Susan Muller, DMD, MS | Sub-Investigator |
| | Amy Chen, MD | Sub-Investigator |
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Maryland |
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Baltimore |
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| | | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| | Nancy Tsottles |
Ph: 410-614-5483 |
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Email:
tsottna@jhmi.edu |
| | Shanthi Marur, MD | Principal Investigator |
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Minnesota |
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Minneapolis |
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| | | University of Minnesota Otolaryngology Department |
| | Kate Cole |
Ph: 612-625-5602 |
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Email:
colex006@umn.edu |
| | Frank Ondrey, MD | Principal Investigator |
| | Edward Greeno, MD | Sub-Investigator |
| | Priya Kumar, MD | Sub-Investigator |
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Ohio |
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Cleveland |
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| | | Ireland Cancer Center/Division od Hematology |
| | Shelly Carr |
Ph: 216-844-1545 |
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Email:
rochelle.carr@uhhospitals.org |
| | Panayiotis Savvides, MD | Principal Investigator |
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Oregon |
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Portland |
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| | | Oregon Health and Science University Cancer Institute |
| | Erin Neal |
Ph: 503-494-7702 |
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Email:
trials@ohsu.edu |
| | Ann Gramza, MD | Principal Investigator |
| | Kathryn Schuff, MD | Sub-Investigator |
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West Virginia |
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Morgantown |
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| | | Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
| | Sylvia McEwuen, RN OCN |
Ph: 304-293-1683 |
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Email:
smcewuen@hsc.wvu.edu |
| | Scot Remick, MD | Principal Investigator |
| | Ramin Altaha | Sub-Investigator |
| | Thomas Hogan | Sub-Investigator |
| | Miklos Auber | Sub-Investigator |
| | Charles Beall | Sub-Investigator |
| | William Petros | Sub-Investigator |
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India |
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Hyderabaad |
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| | | Mediciti Hospital |
| | Naveen Reddy, MD |
Ph: 9848045814 |
| | N. V. S. Ramakrishna, MD | Principal Investigator |
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Manipal |
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| | Shirdi Sai Baba Cancer Hospital |
| | Arpita Bhdra | |
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Email:
arpita.bhadra@acunovalife.com |
| | Contact Person |
Ph: 91-8202922579 |
| | M. S. Vidyasagar, MD | Principal Investigator |
| | Anjali Kakria, MD | Sub-Investigator |
| | Gunjan Baijal, MBBS | Sub-Investigator |
| | Mohan B. Amberkar, MD | Sub-Investigator |
| | Donald J Fernandes, MD | Sub-Investigator |
| | K. L Bairy, MD | Sub-Investigator |
| | P. U. Prakash Saxena, MBBS | Sub-Investigator |
| | Manna Valiathan, MD | Sub-Investigator |
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Mumbai |
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| | Tata Memorial Hospital |
| | Namrata Patil, MD |
Ph: 912224177211 |
| | Dr. Sengar, MD | Principal Investigator |
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New Delhi |
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| | All India Institute of Medical Sciences |
| | Kamalijeet Singh, MD |
Ph: 91-1126593530 |
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Email:
kamaljeets@yahoo.com |
| | C. S. Bal, MD | Principal Investigator |
| | Rajeev Narang, MD | Sub-Investigator |
| | Chitura Sarkar, MD | Sub-Investigator |
| | P. K. Julka, MD | Sub-Investigator |
| | Apollo Cancer Institute |
| | Jaibhagwan Tanwar |
Ph: 91-011-26925825 |
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Email:
jaibhagwan_tanwar@yahoo.co.in |
| | Sameer Kaul, MS | Principal Investigator |
| | Feroz Pasha, MS | Sub-Investigator |
| | Sumaid Kaul, MD | Sub-Investigator |
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Pune |
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| | Ruby Hall Clinic |
| | Bhushan Shinde, MD |
Ph: 919890661341 |
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Email:
drbhooshanshinde@gmail.com |
| | S.M. Karandikar, MD | Principal Investigator |
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Israel |
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Tel-Aviv |
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| | | Tel-Aviv Sourasky Medical Center |
| | Orit Bar-AM |
Ph: 972-3-697-4833 |
| | Rami Ben-Yosef, M.D. | Principal Investigator |
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Italy |
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Milano |
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| | | Lo Studio E la Cura |
| | Laura Locati, MD |
Ph: 390223902765 |
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Email:
laura.locati@istitutotumori.mi.it |
| | Lisa Licitra, MD | Principal Investigator |
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Padova |
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| | Istituto Oncologico Veneto (IOV) - IRCCS |
| | Haralabos Koussis, MD |
Ph: 390498215931 |
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Email:
drbabis@libero.it |
| | Haralabos Koussis, MD | Principal Investigator |
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Pisa |
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| | Azienda Ospedaliero - Universitaria Pisana |
| | Rossella Elisei |
Ph: 39-050995120 |
| | Aldo Pinchera, MD | Principal Investigator |
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Poland |
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Gliwice |
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| | | Zaklad Medyczny Nuklearnej i Endykrynologii |
| | Jolanta Krajewska, MD |
Ph: 48-32-278-99-31 |
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Email:
bjarzab@io.gliwice.pl |
| | Barbara Jarzab, MD | Principal Investigator |
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Warszawa |
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| | Klinika Nowotworow Glowy i Szyji |
| | Jacek Galczynski, MD |
Ph: 48-22-546-22-08 |
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Email:
galczynski@coi.waw.pl |
| | Grzegorz Luboinski, MD | Principal Investigator |
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Republic of Bulgaria |
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Sofia |
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| | | Specialized Hospital for Active Treatment of Oncology |
| | Antoaneta Foneva |
Ph: 359,889,695,106 |
| | Konstanca Timcheva, MD | Principal Investigator |
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Romania |
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Cluj-Napoca |
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| | | Institutul Oncologic |
| | Dana Iancu, MD |
Ph: 40745364515 |
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Email:
dana_iancu2004@yahoo.com |
| | Tudor Eliade Ciuleanu, MD | Principal Investigator |
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Craiova |
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| | SC Meditech SRL |
| | Michael Schenker, MD |
Ph: 0040-351-404-814 |
| | Dan Lungulescu, MD | Principal Investigator |
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Iasi |
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| | Centr of Medical Oncology |
| | Mihail Andronic, MD |
Ph: 40 746 110 096 |
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Email:
anmihail@yahoo.com |
| | Constantin Volovat, MD | Principal Investigator |
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Sibiu |
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| | Clinical County Hospital Sibiu |
| | Valeria V Valeanu, MD | |
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Email:
lauravaleany1990@yahoo.com |
| | Monica Patran, MD | Principal Investigator |
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Suceava |
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| | Emergency Clinical County Hospital "Sf. loan cel Nou" |
| | Iulia Sava, MD |
Ph: 40 230 421 110 |
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Email:
savaiulia@gmail.com |
| | Silvia Ginghina, MD |
Ph: 40 230 421 110 |
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Email:
ging_silvia@yahoo.com |
| | Doina Elena Motan Ganea, MD | Principal Investigator |
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Russia |
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Saint Petersburg |
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| | | St. Petersburg City Oncological Dispensary |
| | Kutukova Svetlana Igorevna |
Ph: 7812756990 |
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Email:
goronkod@zdrav.spb.ru |
| | Georgiy M Manikhas, MD | Principal Investigator |
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Ukraine |
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Lomonosova 33/43 |
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| | | Ukrainian Academy of Medical Science |
| | Dr. Korobko Yevgen, MD |
Ph: 380442577640 & 38067702855 |
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Email:
dr_korobko@ukr.net |
| | Volodymyr Protsyk, MD | Principal Investigator |
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United Kingdom |
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London |
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| | | Royal Marsden Hospital and Institute of Cancer Research |
| | Mary Anne Tanay |
Ph: 442073528171 Ext.1998 |
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Email:
MaryAnne.Tanay@rmh.nhs.uk |
| | Christopher Nutting, MD | Principal Investigator |
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Scotland |
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Glasgow |
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| | | Beatson West of Scotland Cancer Centre |
| | Gemma Tait |
Ph: 44+ 141 301 7218 |
| | Nick Reed, MD | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00507429 Information obtained from ClinicalTrials.gov on September 26, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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