Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00217555
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 21, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cavity cancer.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Drug: gemcitabine hydrochloride Drug: topotecan hydrochloride Phase 2

Detailed Description:



  • Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary peritoneal cavity cancer.
  • Determine the response rate in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.


  • Determine the duration of progression-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline, on day 1 of courses 2, 4, and 6, and then at 1 year.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 36-45 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan
Study Start Date : July 2002
Actual Primary Completion Date : February 2006

Primary Outcome Measures :
  1. Toxicity
  2. Response rate
  3. Quality of life

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival

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


  • Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer
  • Recurrent or persistent platinum-refractory disease, as defined by 1 of the following:

    • Progressive disease while on a platinum compound
    • Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy
    • Recurrent disease within 6 months after completion of therapy
  • Measurable or evaluable disease

    • Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests)
    • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan



  • 18 and over

Performance status

  • GOG 0-3

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN


  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 50 mL/min


  • No clinically significant infection
  • No other severe medical condition that would preclude study treatment
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug
  • At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified


  • At least 3 weeks since prior radiotherapy and recovered


  • Recovered from recent prior surgery

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 identifier (NCT number): NCT00217555

United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Barbara A. Goff, MD University of Washington

Publications of Results: Identifier: NCT00217555     History of Changes
Other Study ID Numbers: PSOC 1901
CDR0000441309 ( Registry Identifier: PDQ )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors