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Chemotherapy +/− Bevacizumab for Ovarian Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- 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)
- 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.
- 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
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."
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."
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."
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."
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."
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."
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."
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