This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
Beth Edelheit, Benaroya Research Institute Identifier:
First received: June 20, 2006
Last updated: April 29, 2015
Last verified: April 2015
The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.

Condition Intervention Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Topotecan Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

Resource links provided by NLM:

Further study details as provided by Beth Edelheit, Benaroya Research Institute:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ]
    Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.

Secondary Outcome Measures:
  • Evaluation of Overall Survival [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ]
    Overall survival was defined as the number of months after commencing study treatment to death.

  • Objective Response Rate [ Time Frame: Response ]
    RECIST criteria

  • Number or Participants With Toxicity [ Time Frame: measured at each treatment cycle ]

Enrollment: 40
Study Start Date: June 2006
Study Completion Date: August 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
Drug: Topotecan
Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
Other Name: Hycamtin
Drug: Bevacizumab
bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
Other Name: Avastin

Detailed Description:
This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen
  • must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line)
  • must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral CT) OR elevated CA-125 (> 100 on two occasions at least one week apart
  • performance status greater than or equal to 70%

Exclusion Criteria:

  • prior treatment with anti-angiogenesis agent
  • treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)
  • evidence of other malignancy within 3 years of study enrollment
  • history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation
  • history of intra-abdominal abscess with 6 months prior to day 0
  • pregnant or lactating patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00343044

United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Puget Sound Oncology Consortium (PSOC)
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Benaroya Research Institute
Genentech, Inc.
Principal Investigator: Kathryn McGonigle, MD Virginia Mason Medical Center
  More Information

Additional Information:
Responsible Party: Beth Edelheit, Thomas Malpass, MD, Kathryn McGonigle, MD, Benaroya Research Institute Identifier: NCT00343044     History of Changes
Other Study ID Numbers: 3040200
AVF3648s ( Other Identifier: GSK )
Study First Received: June 20, 2006
Results First Received: July 29, 2013
Last Updated: April 29, 2015

Keywords provided by Beth Edelheit, Benaroya Research Institute:
platinum resistant ovarian cancer
recurrent ovarian cancer
platinum resistant cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017