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

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ClinicalTrials.gov Identifier: NCT00343044
Recruitment Status : Completed
First Posted : June 22, 2006
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Collaborators:
GlaxoSmithKline
Genentech, Inc.
Information provided by (Responsible Party):
Beth Edelheit, Benaroya Research Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Topotecan Drug: Bevacizumab Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
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
Study Start Date : June 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : August 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Objective Response Rate [ Time Frame: Response ]
    RECIST criteria

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

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343044


Locations
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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
GlaxoSmithKline
Genentech, Inc.
Investigators
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Principal Investigator: Kathryn McGonigle, MD Virginia Mason Medical Center
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Beth Edelheit, Thomas Malpass, MD, Kathryn McGonigle, MD, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT00343044    
Other Study ID Numbers: 3040200
AVF3648s ( Other Identifier: GSK )
First Posted: June 22, 2006    Key Record Dates
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015
Last Verified: April 2015
Keywords provided by Beth Edelheit, Benaroya Research Institute:
platinum resistant ovarian cancer
recurrent ovarian cancer
platinum resistant cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Fallopian Tube Diseases
Bevacizumab
Topotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action