Neoadjuvant Therapy for Ovarian Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Jason D. Wright
Study ID
NCT01146795
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    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.
  • Paclitaxel — DRUG
    Paclitaxel 175 mg/m2 over 3 hours day 1 every 3 weeks in combination with Carboplatin and Bevacizumab.
  • Bevacizumab — DRUG
    Bevacizumab 15 mg/kg day 1 every 3 weeks in combination with Paclitaxel and Carboplatin.

Study Details

This study is to determine the feasibility of administering neoadjuvant carboplatin, paclitaxel, and bevacizumab without excessive dose modification or cycle delay in patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. This study will also investigate the rate of optimal cytoreduction, response rate and progression free and overall survival, and to assess the quality of life for patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer treated with neoadjuvant carboplatin, paclitaxel and bevacizumab.

Key Dates

First listed
Jun 22, 2010
Start date
May 17, 2010
Status verified
Jan 2021
Primary completion
Apr 13, 2015
Completion
Apr 13, 2015

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in New York, NY

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Columbia University Medical Center· New York, NYFox Chase Cancer Center· Philadelphia, PAUniversity of Virginia· Charlottesville, VA

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