Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)

This study has been completed.
Sponsor:
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Richard Thomas Penson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00129727
First received: August 10, 2005
Last updated: April 24, 2016
Last verified: April 2016
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Carboplatin, Paclitaxel and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • PFS [ Time Frame: Median PFS in months - up to 5 years ] [ Designated as safety issue: No ]
    Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer


Secondary Outcome Measures:
  • Response Rate (RECIST-1) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.

  • Toxicity [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    Per CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study


Enrollment: 62
Study Start Date: June 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase II
Paclitaxel carboplatin bevacizumab
Drug: Paclitaxel
Given intravenously
Other Name: Taxol
Drug: Carboplatin
Given intravenously
Other Name: CBDCA
Drug: Bevacizumab
Given intravenously
Other Name: Avastin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129727

Sponsors and Collaborators
Massachusetts General Hospital
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Richard T Penson, MRCP MD MGH
  More Information

Additional Information:
Responsible Party: Richard Thomas Penson, Clin Dir Med Gyn Onc, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00129727     History of Changes
Other Study ID Numbers: 04-247 
Study First Received: August 10, 2005
Results First Received: July 20, 2011
Last Updated: April 24, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Manuscript was published in JCO

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016