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Alkylating agents
Chemotherapy +/− Bevacizumab for Ovarian Cancer
Phase 3
Waitlist Available
Led By Robert L Coleman
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
Patients with specific histologic epithelial cell types are eligible
Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1. prior to cycle 1 (baseline), 2. prior to cycle 3 (6 weeks post cycle 1), 3. prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Awards & highlights
Study Summary
This trial is studying carboplatin, paclitaxel, and gemcitabine hydrochloride given together with or without bevacizumab after surgery to treat patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.
Who is the study for?
This trial is for patients with recurrent ovarian, epithelial, primary peritoneal, or fallopian tube cancer who responded well to initial platinum-taxane therapy and had a treatment-free period of at least 6 months. They must have measurable disease and be in good physical condition (GOG performance status of 0-2). Exclusions include those with more than one prior chemo regimen, previous radiotherapy to the abdomen/pelvis, certain other cancers within the last 5 years, severe medical problems unrelated to cancer, significant bleeding risks or CNS disease.Check my eligibility
What is being tested?
The study tests if combining chemotherapy drugs carboplatin, paclitaxel and gemcitabine hydrochloride with the immunotherapy drug bevacizumab is more effective post-surgery than chemotherapy alone for treating recurrent ovarian-related cancers. Patients are randomly assigned to receive either just chemo or chemo plus bevacizumab after surgery.See study design
What are the potential side effects?
Possible side effects include fatigue; nausea; hair loss from chemotherapy; high blood pressure; bleeding or blood clots from bevacizumab. There's also a risk of infection due to lowered white blood cell counts and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is of a specific type affecting the lining of organs.
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My cancer responded completely to my initial platinum-taxane therapy.
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My cancer responded completely to initial chemotherapy, with normal exams and CA125 levels.
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I haven't had cancer treatment for 6 months and my cancer hasn't worsened.
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I am receiving or have received initial treatment that includes maintenance therapy after a complete response.
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I can take care of myself but might not be able to do heavy physical work.
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I agree to let a random selection decide my surgery type.
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My cancer has come back and can be observed.
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My ovarian, peritoneal, or fallopian tube cancer has come back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1. prior to cycle 1 (baseline), 2. prior to cycle 3 (6 weeks post cycle 1), 3. prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1. prior to cycle 1 (baseline), 2. prior to cycle 3 (6 weeks post cycle 1), 3. prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
Secondary outcome measures
Patient Reported Physical Function (Chemotherapy Analysis)
Patient Reported Physical Functioning (Surgery Analysis)
Patient Reported Quality of Life (Chemotherapy Analysis)
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)Experimental Treatment5 Interventions
Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.
Group II: Arm III (gemcitabine hydrochloride, carboplatin)Experimental Treatment4 Interventions
Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.
Group III: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab)Experimental Treatment6 Interventions
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days.
Group IV: Arm I (paclitaxel, docetaxel, carboplatin)Active Control5 Interventions
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,101 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
99,800 Total Patients Enrolled
Robert L ColemanPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will start treatment with bevacizumab in my second cycle after surgery to reduce my tumor.My cancer is of a specific type affecting the lining of organs.My cancer responded completely to my initial platinum-taxane therapy.I am currently receiving immunotherapy or radiotherapy.I have not had radiation therapy to my abdomen or pelvis.I have not had surgery to remove cancer that came back.My previous cancer diagnosis fits the trial's requirements.I have an infection that is not responding to treatment.I haven't had cancer treatment for 6 months and my cancer hasn't worsened.I am receiving or have received initial treatment that includes maintenance therapy after a complete response.I can take care of myself but might not be able to do heavy physical work.I have not had chemotherapy for any abdominal or pelvic tumor except for ovarian, fallopian tube, or primary peritoneal cancer.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am not pregnant, nursing, or able to become pregnant without using effective birth control.I do not have any conditions that cause serious bleeding.I have not had major surgery, dental surgery, or significant injury recently.I am having surgery not aimed at reducing my cancer before starting treatment.My cancer responded completely to initial chemotherapy, with normal exams and CA125 levels.I agree to let a random selection decide my surgery type.I had an allergic reaction to chemotherapy but was successfully treated with a desensitization program.My cancer has come back and can be observed.Your disease must have at least one measurable lesion that can be accurately measured.I do not have a history or signs of specific brain or spinal cord diseases.I have never had endometrial cancer.I do not have any major heart conditions.My ovarian, peritoneal, or fallopian tube cancer has come back.Patients need to have specific blood and body chemistry levels.I have had only one chemotherapy regimen for my condition.I need IV fluids or nutrition due to partial bowel blockage or a tear.I haven't had any cancer besides non-melanoma skin cancer in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (paclitaxel, docetaxel, carboplatin)
- Group 2: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab)
- Group 3: Arm III (gemcitabine hydrochloride, carboplatin)
- Group 4: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)
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.
What is the goal of this medical study?
"The objective of this long-term study is to compare the efficacy of bevacizumab against second-line paclitaxel and carboplatin in patients with recurrent platinum sensitive epithelial ovarian, peritoneal primary or fallopian tube cancer. Secondary outcomes being assessed include chemotherapy's effects on quality of life and physical function, as measured by the TOI scale and RAND SF-36 respectively."
Answered by AI
How many people are enrolling in this clinical trial?
"Currently, this clinical trial is not enrolling patients. The study was posted on December 6th 2007 and updated October 14th 2022. If you are looking for other studies, 4177 trials are actively enrolling patients with ovarian brenner tumor and 1973 trials for Bevacizumab are admitting participants."
Answered by AI
How many different locations are participating in this trial?
"The primary locations for this clinical trial are Penn State Milton S Hershey Medical Center in Hershey, Pennsylvania, Palo Alto Medical Foundation Health Care in Palo Alto, California, and Olympic Medical Cancer Care Center in Sequim, Washington. Additionally, there are 100 other sites spread across the country."
Answered by AI
Could you please tell me about other research Bevacizumab has been used in?
"City of Hope Comprehensive Cancer Center first studied bevacizumab in 1997. Out of the 4097 completed clinical trials, 1973 are still active. A large percentage of these ongoing studies are based in Hershey, Pennsylvania."
Answered by AI
Are there any current vacancies for this research project?
"The listing for this clinical trial on clinicaltrials.gov says that patient recruitment is currently closed. The study was first posted on December 6th, 2007 and was last updated on October 14th, 2022. Although this particular trial isn't enrolling right now, there are over 6000 other trials that are still looking for patients to participate."
Answered by AI
Has Bevacizumab been cleared by the FDA?
"Bevacizumab has received a score of 3 for safety. This is because it is a phase 3 trial, meaning that there is evidence from earlier stages to support both efficacy and safety."
Answered by AI
What are the common indications for Bevacizumab?
"Bevacizumab can be used to shrink or stop the growth of cancer in patients with head and neck cancer that has spread to other parts of the body, as well as non-Hodgkin lymphoma."
Answered by AI
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