Avastin in Combination Wtih Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma
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.
Fallopian Tube Cancer
Malignant Tumor of Peritoneum
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free Survival (PFS) at 6 Months [ Time Frame: 6 months per participant ] [ Designated as safety issue: No ]Progression-Free Survival (PFS): is the 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.
- Duration of PFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Duration of Response: Time in months of stable disease, complete response or partial response to progressive disease. Stable Disease: Any condition not meeting the other RECIST criteria (CR, PR, PD, Symptomatic Deterioration).
Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions is documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125 level, if elevated at baseline.
- Response Rate (RR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum longest diameter (LD). There can be no unequivocal progression of nontarget lesions and no new lesions. Documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured only by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. A PR according to CA-125 levels has occurred if a 50% decrease in the level from the 2 elevated baseline levels, and must be confirmed by a 4th sample at least 28 days after the prior sample OR a 75% serial decrease in CA-125 levels occurs over 3 samples. Final sample must be analyzed at least 28 days after the prior sample.
Symptomatic Deterioration: A global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of PD.
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]The final safety analysis will include all patients who receive at least one dose of any study drug. The incidence of serious adverse experiences (SAEs) treatment related will be summarized by type and severity and exact 95% confidence intervals (CIs) for the rates of such SAEs will be computed.
- Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]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) will be analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.
|Study Start Date:||March 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Combination Therapy
Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Response assessment every 3 cycles (9 weeks).
15 mg/kg, In 100 ml NS IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle
Other Names:Drug: Docetaxel
40 mg/m^2, In 250 ml D5W or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle
Other Name: TAXOTERE®
|United States, Florida|
|Broward General Medical Center Cancer Center|
|Fort Lauderdale, Florida, United States, 33316|
|Women's Cancer Associates|
|Saint Petersburg, Florida, United States, 33701|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, North Carolina|
|Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Robert M. Wenham, MD||H. Lee Moffitt Cancer Center and Research Institute|