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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Objective Tumor Response
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Patient Reported Neurotoxicity
+2 moreOther outcome measures
Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene
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
Oxaliplatin
2011
Completed Phase 4
~2560
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
231 Previous Clinical Trials
100,802 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,103 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
David M GershensonPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
2,260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.You are expected to live for more than 3 months.I had minor surgery or biopsy over a week ago and my wound is healing well.I have been diagnosed with primary peritoneal carcinoma.I haven't had a heart attack or unstable chest pain in the last year.I do not have conditions that increase my risk of bleeding significantly.I had surgery for ovarian or fallopian tube cancer, including an appendectomy.Your prothrombin time test must be within a certain range.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.I have no history of brain tumors, brain metastases, or uncontrolled seizures.I have had treatment for gynecologic or colorectal cancer but not breast cancer before joining.I am not expected to undergo major surgery during the study.I do not have serious heart issues or a history of certain heart treatments with a low ejection fraction.I have mild leg pain when I exercise due to poor blood flow.I have not had a stroke or similar event in the last 6 months.I will start the trial treatment within 10 weeks of my first surgery or within 14 days of joining the trial if my cancer has returned.I have had a blood clot in my lungs or legs in the last 6 months.I have a condition that prevents me from taking pills.My kidney function, measured by creatinine levels, is within normal limits.My cancer is stage II-IV without brain metastasis or is a recurrent stage I.My tumor is considered to be slow-growing.Your white blood cell count is 3,000 or higher.Your blood clotting time is not more than 1.5 times the normal level.I have not had an abdominal fistula or perforation in the last year.My ovarian cancer is of mixed epithelial type.Your hemoglobin level is at least 10 grams per deciliter, even if you had a blood transfusion to reach this level.You need to have at least 100,000 platelets per microliter of blood.Your SGOT blood test result is not more than 2.5 times the normal level.Your alkaline phosphatase level should be less than or equal to 2.5 times the upper limit of normal.I have or had colon cancer.You are allergic to Chinese hamster cell products or other similar antibodies.I have ovarian or fallopian tube cancer with minimal remaining disease after surgery.Your ANC level is at least 1,500 per microliter.I have acute hepatitis or an infection needing IV antibiotics.Your bilirubin levels are not higher than 1.5 times the upper limit of normal.My physical ability is good to moderate due to my condition.I am currently taking warfarin.My blood pressure is not higher than 150/100 mm Hg.My nerve damage does not significantly affect my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (carboplatin, paclitaxel, bevacizumab)
- Group 2: Arm IV (oxaliplatin, capecitabine, bevacizumab)
- Group 3: Arm I (carboplatin and paclitaxel)
- Group 4: Arm II (oxaliplatin and capecitabine)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is Bevacizumab most often used?
"Bevacizumab has been cleared by the FDA for the treatment of non-hodgkin lymphoma, as well as recurrent cervical cancer, locally advanced non-small cell lung cancer, and initial treatment."
Answered by AI
Could you please provide some context for Bevacizumab's efficacy?
"City of Hope Comprehensive Cancer Center conducted the first clinical trial for bevacizumab in 1997. Out of the 3632 total completed trials, 1946 are still recruiting patients. These trials are based in many locations, but a significant concentration can be found in Des Moines, Iowa."
Answered by AI
How many people are test subjects in this investigation at most?
"Unfortunately, this particular trial is not currently searching for any participants. Although, it is important to note that this study was most recently updated on 9/23/2022. Additionally, if you are interested in other similar studies, there are currently 3798 trials for relapse and 1946 trials for Bevacizumab that are actively looking for participants."
Answered by AI
Are we still looking for participants in this experiment?
"Unfortunately, this particular clinical trial is no longer admitting patients. It was originally posted on October 12th, 2010 but the last update was on September 23rd, 2022. For patients who are still interested in participating in clinical trials, there are currently 3798 trials for relapse and 1946 for Bevacizumab that are actively recruiting."
Answered by AI
Are there any dangers that patients should be aware of when using Bevacizumab?
"There is both efficacy and safety data from past trials to support the use of Bevacizumab, so it received a score of 3."
Answered by AI
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