Clinical Trial: Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy

Brief Summary: The purpose of this study is to evaluate the effectiveness of the combination of Avastin and Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian cancer within 12 months of platinum chemotherapy.

Detailed Summary:
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Six Month Progression Free Survival (PFS) [ Time Frame: 6 months per participant ]

Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.

Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.



Original Primary Outcome: Progression-free Survival (PFS) at 6 Months

Current Secondary Outcome:

  • Median Progression Free Survival [ Time Frame: Up to 5 years ]

    PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.

    Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.

  • Overall Response Rate (RR) [ Time Frame: Up to 5 years ]
    Overall Response: Complete Response (CR) + Partial Response (PR). To determine the response rate (RR) of the investigational treatment regimen. Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.
  • Occurrence of Grade 3 or 4 Toxicity [ Time Frame: Up to 4 years ]
    Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles. Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.


Original Secondary Outcome:

  • Duration of PFS
  • Response rate
  • Safety profile
  • Overall survival


Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: July 17, 2007
Date Started: March 2007
Date Completion:
Last Updated: January 7, 2014
Last Verified: May 2013