Neoadjuvant Therapy for Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01146795|
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer||Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab||Phase 2|
Initial treatment for ovarian cancer is usually surgical cytoreduction followed by adjuvant platinum and taxane chemotherapy. At the time of diagnosis over 75% of patients present with stage III or IV disease that has spread into the peritoneal cavity or distally. Despite a number of new chemotherapeutic regimens survival has improved only modestly over the preceding two decades. While overall 5-year survival has improved from 30% to 50%, 5-year survival remains only 25% for women with advanced stage disease. Given these findings it is clear that improved strategies for the delivery of cytotoxic and biologic agents are needed for women with advanced stage epithelial ovarian cancer.
A newer drug, called bevacizumab, has been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy in patients with colon cancer, lung cancer, and some types of breast cancer that have spread to distant sites in the body. A critical question which will need to be answered is whether or not it is feasible to administer a combination of bevacizumab with standard cytotoxic therapy using a neo-adjuvant approach for patients with epithelial cancer of the ovary, fallopian tube, or primary peritoneum.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Carboplatin, Paclitaxel and Bevacizumab Neoadjuvant Therapy for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer|
|Actual Study Start Date :||May 17, 2010|
|Actual Primary Completion Date :||April 13, 2015|
|Actual Study Completion Date :||April 13, 2015|
Experimental: Carboplatin, Paclitaxel, and Bevacizumab
Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab.
After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. Patients must fulfill all criteria to be considered eligible for surgical exploration: 1) ≥50% reduction in pretreatment cancer antigen 125 (CA-125) and 2) No medical contraindications to surgery.
After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure. Bevacizumab will be omitted from cycle 4 of chemotherapy. Patients who do NOT undergo surgical resection should receive cycles 4-9 of therapy. In this instance bevacizumab may be included in cycle 4.
Carboplatin will be administered at a concentration-time curve (AUC) of 5-6 (at the discretion of the physician) day 1 every 3 weeks in combination with Paclitaxel and Bevacizumab.
Other Name: Paraplatin
Paclitaxel 175 mg/m2 over 3 hours day 1 every 3 weeks in combination with Carboplatin and Bevacizumab.
Other Name: Taxol
Bevacizumab 15 mg/kg day 1 every 3 weeks in combination with Paclitaxel and Carboplatin.
Other Name: Avastin
- Number of Protocol Defined Adverse Events in Patients Receiving Neoadjuvant Carboplatin, Paclitaxel, and Bevacizumab [ Time Frame: Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months) ]
This is to assess the feasibility of delivering multiple cycles of the study treatment without excessive dose modification or cycle delays. The regimen would be considered unfeasible for further study if there were 5 or more of the following events within the first 15 patients, 7 or more of these events within the first 30 patients, or 8 or more of these events within the first 45 patients:
- Delay of day 1 of therapy > 3 weeks from the expected day 1 of that cycle
- Febrile neutropenia requiring hospitalization
- Grade 4 thrombocytopenia
- Grade 1-5 gastrointestinal perforation
- Grade 3-4 hemorrhagic toxicity
- Grade 3-4 arterial thromboembolic complications
- Grade 4 hypertension
- Grade 4 proteinuria
- Fascial dehiscence
- Response Rate [ Time Frame: Cycle 3, Cycle 6, Cycle 9 and 3 years post-treatment ]The percentage of patients whose cancer shrinks or disappears after treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Quality of Life (QOL) Score [ Time Frame: Baseline, Cycle 3, Cycle 6, Cycle 9 ]The FACT Quality of Life (QOL) Score questionnaire is designed to assess the effects of cancer and its treatment on the quality of life, by measuring aspects of an individual's sense of well-being and ability to carry out various activities. When calculating the total QOL score, the score scale of functional well-being was reversed in order to keep consistent with other three domains. The lower the total score, the better the quality of life. The five-point scale ranges from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a simple sum of item scores. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. With a total possible score greater than 100, additional scoring methods have been used to simplify interpretation. Modifications of scoring include normalizing the total score on a scale of 0-100 through mathematical transformations, as well as the use of a Trial Outcome Index (TOI).
- Progression-free Survival (PFS) [ Time Frame: Up to 3 years ]The length of time during and after the treatment of cancer, that a patient lives with the disease but it does not get worse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146795
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Jason D Wright, MD||Columbia University|