Chemotherapy +/− Bevacizumab for Ovarian and Fallopian Tube Cancer

Recruiting at 283 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.

Research Team

David M Gershenson

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with newly diagnosed stage II-IV or recurrent stage I epithelial ovarian or fallopian tube cancer who've had surgery and are within certain health parameters (like normal organ function tests). They must not have received prior treatment for gynecologic or colorectal cancer, have no severe allergies to specific antibodies, no recent history of significant cardiovascular events, and agree to effective birth control if applicable.

Inclusion Criteria

Your urine test should show low levels of protein, and if it shows higher levels, another test will be done to make sure it's not too high.

You are expected to live for more than 3 months.

I had surgery for ovarian or fallopian tube cancer, including an appendectomy.

Exclusion Criteria

I have not had any cancer other than non-melanoma skin cancer in the past 5 years.

I have not had surgery or an open biopsy in the last 4 weeks.

I had minor surgery or biopsy over a week ago and my wound is healing well.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Capecitabine (Anti-metabolites)
• Carboplatin (Alkylating agents)
• Oxaliplatin (Alkylating agents)
• Paclitaxel (Anti-tumor antibiotic)

Trial Overview The study compares two chemotherapy regimens: Carboplatin with Paclitaxel versus Oxaliplatin with Capecitabine. Both may be given with Bevacizumab, a monoclonal antibody. The goal is to determine which combination is more effective as first-line therapy in treating these cancers.

Participant Groups

Group I: Arm IV (oxaliplatin, capecitabine, bevacizumab) Experimental Treatment 5 Interventions

Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.

Group II: Arm III (carboplatin, paclitaxel, bevacizumab) Experimental Treatment 5 Interventions

Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Group III: Arm II (oxaliplatin and capecitabine) Experimental Treatment 4 Interventions

Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Group IV: Arm I (carboplatin and paclitaxel) Experimental Treatment 4 Interventions

Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+