Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)

NCT00129727 | Completed Phase 2 Results DMC

• 1 other identifier: 04-247
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

Carboplatin; Paclitaxel; Bevacizumab; Ovarian; Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  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

  Median PFS in months - up to 5 years

Secondary Outcomes (2)

• Response Rate (RECIST-1)

  5 years

• Toxicity

  60 months

Study Arms (1)

Phase II

EXPERIMENTAL

Paclitaxel carboplatin bevacizumab

Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab

Interventions

Paclitaxel DRUG

Given intravenously

Also known as: Taxol

Phase II

Carboplatin DRUG

Given intravenously

Also known as: CBDCA

Phase II

Bevacizumab DRUG

Given intravenously

Also known as: Avastin

Phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Women and Infants Hospital of Rhode Island: collaborator

Related Links

• URL is the published abstract

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

Paclitaxel; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Phase II uncontrolled trial

Results Point of Contact

• Title: Richard T Penson MD MRCP
• Organization: Massachusetts General Hospital

rpenson@partners.org

617-726-5867

Study Officials

• Richard T Penson, MRCP MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clin Dir Med Gyn Onc

Study Record Dates

• First Submitted: August 10, 2005
• First Posted: August 12, 2005
• Study Start: June 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 1, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share