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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 18 and over Pharmaceutical / Industry OXC4T4-302 NCT00507429

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

U.S.A.
California
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Gina Tse	Ph: 323-865-0514
			Email: tse_g@ccnt.hsc.usc.edu
		Charlean Ketchens	Ph: 323-226-2452
			Email: ketchens_c@ccnt.hsc.usc.edu
		Barbara Gitlitz, MD	Principal Investigator
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Brittany Hines	Ph: 720-848-0634
			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
Connecticut
	New Haven
	Yale Cancer Center
		Janice Napoletano	Ph: 203-785-7562
			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
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Austin Hamilton	Ph: 404-778-4151
			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
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Nancy Tsottles	Ph: 410-614-5483
			Email: tsottna@jhmi.edu
		Shanthi Marur, MD	Principal Investigator
Minnesota
	Minneapolis
	University of Minnesota Otolaryngology Department
		Kate Cole	Ph: 612-625-5602
			Email: colex006@umn.edu
		Frank Ondrey, MD	Principal Investigator
		Edward Greeno, MD	Sub-Investigator
		Priya Kumar, MD	Sub-Investigator
Ohio
	Cleveland
	Ireland Cancer Center/Division od Hematology
		Shelly Carr	Ph: 216-844-1545
			Email: rochelle.carr@uhhospitals.org
		Panayiotis Savvides, MD	Principal Investigator
Oregon
	Portland
	Oregon Health and Science University Cancer Institute
		Erin Neal	Ph: 503-494-7702
			Email: trials@ohsu.edu
		Ann Gramza, MD	Principal Investigator
		Kathryn Schuff, MD	Sub-Investigator
West Virginia
	Morgantown
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals
		Sylvia McEwuen, RN OCN	Ph: 304-293-1683
			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
India
	Hyderabaad
	Mediciti Hospital
		Naveen Reddy, MD	Ph: 9848045814
		N. V. S. Ramakrishna, MD	Principal Investigator
	Manipal
	Shirdi Sai Baba Cancer Hospital
		Arpita Bhdra
			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
	Mumbai
	Tata Memorial Hospital
		Namrata Patil, MD	Ph: 912224177211
		Dr. Sengar, MD	Principal Investigator
	New Delhi
	All India Institute of Medical Sciences
		Kamalijeet Singh, MD	Ph: 91-1126593530
			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
			Email: jaibhagwan_tanwar@yahoo.co.in
		Sameer Kaul, MS	Principal Investigator
		Feroz Pasha, MS	Sub-Investigator
		Sumaid Kaul, MD	Sub-Investigator
	Pune
	Ruby Hall Clinic
		Bhushan Shinde, MD	Ph: 919890661341
			Email: drbhooshanshinde@gmail.com
		S.M. Karandikar, MD	Principal Investigator
Israel
	Tel-Aviv
	Tel-Aviv Sourasky Medical Center
		Orit Bar-AM	Ph: 972-3-697-4833
		Rami Ben-Yosef, M.D.	Principal Investigator
Italy
	Milano
	Lo Studio E la Cura
		Laura Locati, MD	Ph: 390223902765
			Email: laura.locati@istitutotumori.mi.it
		Lisa Licitra, MD	Principal Investigator
	Padova
	Istituto Oncologico Veneto (IOV) - IRCCS
		Haralabos Koussis, MD	Ph: 390498215931
			Email: drbabis@libero.it
		Haralabos Koussis, MD	Principal Investigator
	Pisa
	Azienda Ospedaliero - Universitaria Pisana
		Rossella Elisei	Ph: 39-050995120
		Aldo Pinchera, MD	Principal Investigator
Poland
	Gliwice
	Zaklad Medyczny Nuklearnej i Endykrynologii
		Jolanta Krajewska, MD	Ph: 48-32-278-99-31
			Email: bjarzab@io.gliwice.pl
		Barbara Jarzab, MD	Principal Investigator
	Warszawa
	Klinika Nowotworow Glowy i Szyji
		Jacek Galczynski, MD	Ph: 48-22-546-22-08
			Email: galczynski@coi.waw.pl
		Grzegorz Luboinski, MD	Principal Investigator
Republic of Bulgaria
	Sofia
	Specialized Hospital for Active Treatment of Oncology
		Antoaneta Foneva	Ph: 359,889,695,106
		Konstanca Timcheva, MD	Principal Investigator
Romania
	Cluj-Napoca
	Institutul Oncologic
		Dana Iancu, MD	Ph: 40745364515
			Email: dana_iancu2004@yahoo.com
		Tudor Eliade Ciuleanu, MD	Principal Investigator
	Craiova
	SC Meditech SRL
		Michael Schenker, MD	Ph: 0040-351-404-814
		Dan Lungulescu, MD	Principal Investigator
	Iasi
	Centr of Medical Oncology
		Mihail Andronic, MD	Ph: 40 746 110 096
			Email: anmihail@yahoo.com
		Constantin Volovat, MD	Principal Investigator
	Sibiu
	Clinical County Hospital Sibiu
		Valeria V Valeanu, MD
			Email: lauravaleany1990@yahoo.com
		Monica Patran, MD	Principal Investigator
	Suceava
	Emergency Clinical County Hospital "Sf. loan cel Nou"
		Iulia Sava, MD	Ph: 40 230 421 110
			Email: savaiulia@gmail.com
		Silvia Ginghina, MD	Ph: 40 230 421 110
			Email: ging_silvia@yahoo.com
		Doina Elena Motan Ganea, MD	Principal Investigator
Russia
	Saint Petersburg
	St. Petersburg City Oncological Dispensary
		Kutukova Svetlana Igorevna	Ph: 7812756990
			Email: goronkod@zdrav.spb.ru
		Georgiy M Manikhas, MD	Principal Investigator
Ukraine
	Lomonosova 33/43
	Ukrainian Academy of Medical Science
		Dr. Korobko Yevgen, MD	Ph: 380442577640 & 38067702855
			Email: dr_korobko@ukr.net
		Volodymyr Protsyk, MD	Principal Investigator
United Kingdom
	London
	Royal Marsden Hospital and Institute of Cancer Research
		Mary Anne Tanay	Ph: 442073528171 Ext.1998
			Email: MaryAnne.Tanay@rmh.nhs.uk
		Christopher Nutting, MD	Principal Investigator
Scotland
	Glasgow
	Beatson West of Scotland Cancer Centre
		Gemma Tait	Ph: 44+ 141 301 7218
		Nick Reed, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00507429
Information obtained from ClinicalTrials.gov on September 26, 2008