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

NCT00343044 | Completed Phase 2 Results

• 2 other identifiers: 3040200AVF3648s
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

platinum resistant ovarian cancer; recurrent ovarian cancer; platinum resistant cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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.

  PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.

Secondary Outcomes (3)

• Evaluation of Overall Survival

  PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.

• Objective Response Rate

  Response

• Number or Participants With Toxicity

  measured at each treatment cycle

Study Arms (1)

Treatment

EXPERIMENTAL

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; Drug: Bevacizumab

Interventions

Topotecan DRUG

Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.

Also known as: Hycamtin

Treatment

Bevacizumab DRUG

bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.

Also known as: Avastin

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Benaroya Research Institute: lead
• GlaxoSmithKline: collaborator
• Genentech, Inc.: collaborator

Study Sites (2)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Puget Sound Oncology Consortium (PSOC)

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• McGonigle KF, Muntz HG, Vuky J, Paley PJ, Veljovich DS, Greer BE, Goff BA, Gray HJ, Malpass TW. Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer: results of a phase 2 study. Cancer. 2011 Aug 15;117(16):3731-40. doi: 10.1002/cncr.25967. Epub 2011 Feb 24.

  PMID: 21815133 RESULT

Related Links

• Benaroya Research Institute's homepage with listings of clinical trials

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Topotecan; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Thomas Malpass, M.D., Principal Investigator
• Organization: Benaroya Research Institute at Virginia Mason

thomas.malpass@vmmc.org

206-223-6193

Study Officials

• Kathryn McGonigle, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Malpass, MD, Kathryn McGonigle, MD

Study Record Dates

• First Submitted: June 20, 2006
• First Posted: June 22, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: August 1, 2011
• Last Updated: May 15, 2015
• Results First Posted: May 15, 2015

Record last verified: 2015-04

Locations

US (2)