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Monoclonal Antibodies

Chemotherapy +/− Bevacizumab for Ovarian and Fallopian Tube Cancer

Phase 3

Waitlist Available

Led By David M Gershenson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage

Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance > 50 cc/min

Must not have

Patients with primary peritoneal carcinoma

Patients with active bleeding or pathologic conditions that carry a high risk of bleeding such as a known bleeding disorder, coagulopathy or tumor involving the major vessels

Timeline

Screening 3 weeks

Treatment Varies

Follow Up is measured from date of randomization until first indication of progression based on recist criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing two different chemotherapy combinations with or without bevacizumab to see which is more effective in treating ovarian or fallopian tube cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs used, increased risk of bleeding and blood clots due to Bevacizumab, nerve damage from chemotherapy agents leading to sensory/motor issues, digestive problems like nausea and diarrhea, fatigue, and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My kidney function, measured by creatinine levels, is within normal limits.

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My cancer is stage II-IV without brain metastasis or is a recurrent stage I.

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My physical ability is good to moderate due to my condition.

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My nerve damage does not significantly affect my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with primary peritoneal carcinoma.

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I do not have conditions that increase my risk of bleeding significantly.

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I have a serious wound or fracture that's not healing, but I'm eligible if it's being monitored weekly without signs of infection.

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I have no history of brain tumors, brain metastases, or uncontrolled seizures.

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I have had treatment for gynecologic or colorectal cancer but not breast cancer before joining.

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I have mild leg pain when I exercise due to poor blood flow.

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I have not had a stroke or similar event in the last 6 months.

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I do not have serious heart issues or a history of certain heart treatments with a low ejection fraction.

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I have a condition that prevents me from taking pills.

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My ovarian cancer is of mixed epithelial type.

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I have or had colon cancer.

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I have acute hepatitis or an infection needing IV antibiotics.

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I am currently taking warfarin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Objective Tumor Response

Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0

Patient Reported Neurotoxicity

+2 more

Other study objectives

Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm IV (oxaliplatin, capecitabine, bevacizumab)Experimental Treatment5 Interventions

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

Group II: Arm III (carboplatin, paclitaxel, bevacizumab)Experimental Treatment5 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 Treatment4 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 Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Oxaliplatin

2011

Completed Phase 4

~2890