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Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007
Sponsors and Collaborators: Massachusetts General Hospital
Women and Infants Hospital of Rhode Island
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00129727
  Purpose

Study Design: This ia a Phase II study.

Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary peritoneal and papillary serous mullerian tumors will be recruited.

Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle, immediately post-operatively. This will be followed by one year of bevacizumab q21.

Outcomes: Outcomes include toxicity, response rate, and progression free survival.


Condition Intervention Phase
Ovarian Cancer
Drug: Paclitaxel
Drug: Carboplatin
Drug: bevacizumab
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Carboplatin Paclitaxel Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Evaluation of Carboplatin, Paclitaxel and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To examine the toxicity, estimate the objective response rate, and progression free survival of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer [ Time Frame: TBD ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: June 2005
Estimated Study Completion Date: August 2005
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel
    Given intravenously
    Drug: Carboplatin
    Given intravenously
    Drug: bevacizumab
    Given intravenously
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older.
  • Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, primary peritoneal carcinoma or papillary serous mullerian carcinoma.
  • Previous attempted surgical debulking.
  • Stage IC or greater.
  • Performance status 0-2 by the ECOG scale.
  • Peripheral neuropathy < grade 2.
  • Life expectancy must be >= 6 months.
  • Patients must be informed of the investigational nature of the study and sign an informed consent form.

Exclusion Criteria:

  • History of serious systemic disease, including: myocardial infarction within the last 6 months; uncontrolled hypertension (blood pressure of >160/110 mmHg on medication); unstable angina; New York Heart Association (NYHA) Grade II or greater congestive heart failure; unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); or peripheral vascular disease (Grade II or greater). Prior history of thrombotic events and stroke are also included as exclusion criteria.
  • Neutrophil count <1,500/mm3; platelet count <100,000/m3.
  • Alkaline phosphatase or bilirubin > 1.5 x upper limit of normal (ULN); SGOT > 5 x ULN.
  • Calculated creatinine clearance < 50 ml/min.
  • Prior chemotherapy or radiotherapy.
  • Inadequate surgical cytoreduction such that interval cytoreductive surgery could materially improve prognosis. Patients are not permitted to have interval cytoreductive surgery on study.
  • Concurrent invasive malignancy. (Patients with concurrent superficial endometrioid endometrial carcinoma are eligible, if their endometrial carcinoma is superficial or invades less than 50% of the thickness of the myometrium.)
  • Uncontrolled hypertension (defined as a Grade 4 event that has failed to resolve with observation or treatment) or bleeding diathesis.
  • Evidence of tumor involving major blood vessels on any prior computed tomography (CT) scan.
  • Surgical wound that has failed to close.
  • Prior treatment with an anti-angiogenic agent.
  • Any active bleeding.
  • Therapeutic anticoagulation (prophylactic very low dose warfarin is allowed [1mg by mouth (p.o.) once daily (qd) with International Normalized Ratio (INR) <1.2]).
  • Active psychiatric disease or neurologic symptoms requiring treatment (Grade I sensory neuropathy allowed).
  • Presence of central nervous system or brain metastases.
  • Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1g of protein/24 hr to allow participation in the study.
  • Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
  • Patients with known hypersensitivity to Cremophor EL.
  • Patients with active bacterial, viral or fungal infections
  • Patients receiving other investigational therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129727

Contacts
Contact: Richard T Penson, MRCP MD 617-726-5867 rpenson@partners.org
Contact: Maria Roche, NP 617-726-5867 mroche@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard T Penson, MRCP MD     617-726-5867     rpenson@partners.org    
Contact: Maria Roche, NP     617-726-5867     mroche@partners.org    
DF/HCC Recruiting
Boston, Massachusetts, United States, 02114
United States, Rhode Island
Women and Infants Not yet recruiting
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Massachusetts General Hospital
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Richard T Penson, MRCP MD MGH
  More Information

Responsible Party: Massachusetts General Hospital ( Richard Penson, MD )
Study ID Numbers: 04-247
Study First Received: August 10, 2005
Last Updated: January 2, 2008
ClinicalTrials.gov Identifier: NCT00129727  
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Carboplatin
Paclitaxel
Bevacizumab
Ovarian
Cancer

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Carboplatin
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009