Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.

bevacizumab

Panagiotis Konstantinopoulos, MD, PhD

The purpose of this study is to evaluate how the participant's disease (ovarian, primary peritoneal serous, fallopian tube, or papillary serous endometrial cancer) responds to additional treatment with Avastin (bevacizumab). Participants have already received Avastin as part of maintenance therapy for their cancer. Maintenance therapy is a medical therapy that is given to people to prevent a relapse. However, cancer may return after maintenance therapy. This research study hopes to determine whether additional treatment with Avastin will be effective in treating the participant's cancer.

OBJECTIVES:

Primary:

To determine the activity of bevacizumab in patients with epithelial ovarian, primary peritoneal serous, papillary serous endometrial or fallopian tube cancer who relapse after achieving an initial complete response to first-line therapy that included at least 6 month bevacizumab maintenance as defined by: 1) clinical response rate OR 2) clinical benefit response

Secondary:

* To assess duration of progression free survival (PFS)
* To assess the safety
* To correlate response with the Avastin-free interval

STATISTICAL DESIGN:

This study used a two-stage design to evaluate efficacy of bevacizumab based on a patient achieving either clinical response or clinical benefit response. The null and alternative response rates were 10% and 30%. If two or more patients enrolled in the stage one cohort (n=10 patients) achieved response than accrual would proceed to stage two (n=19 patients). If response was achieved by at least 6 patients in the final set of 29 evaluable patients then bevacizumab would be deemed worthy for further study. This design had 80% power given one-sided 0.05 significance level.

Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer

Phase II Study of Single-Agent Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous, Papillary Serous Endometrial or Fallopian Tube Cancer Who Have Recurred After Prior Therapy With Maintenance Avastin

For measurable disease (MD) patients, clinical response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For non-MD patients, clinical response based on modified Gynecologic Cancer Intergroup (GCIG) criteria was defined as at least a 50% decrease in CA-125 levels.

Clinical benefit response was defined as absence of disease progression at 18 weeks (ie after 6 cycles). Disease progression (PD) could occur per RECIST 1.0 or based on CA-125 levels. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Disease progression based on CA-125 level was doubling of the CA-125 level from baseline. For patients with normal baseline CA-125 (who by definition had MD) the criterion for progression based on CA-125 doubling was doubling of CA-125 from the upper limit of normal (i.e. more than 70).

Dana-Farber Cancer Institute

Massachusetts General Hospital

Genentech, Inc.

Beth Israel Deaconess Medical Center

Principal Investigator

Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. There were no SAEs experinced by patients on this study per the above definition.

Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer	NCT00866723	Ovarian Cancer Primary Periton... Fallopian Tube ...	bevacizumab	18 Years -	Dana-Farber Cancer Institute
Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer	NCT00866723	Ovarian Cancer Primary Periton... Fallopian Tube ...	bevacizumab	18 Years -	Dana-Farber Cancer Institute
Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer	NCT00866723	Ovarian Cancer Primary Periton... Fallopian Tube ...	bevacizumab	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for primary peritoneal serous cancer