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

Brief Title

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

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

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.

Detailed Description

      OBJECTIVES:

      Primary

        -  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.

      Secondary

        -  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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Toxicity

Secondary Outcome

 Progression-free survival

Condition

Fallopian Tube Cancer

Intervention

gemcitabine hydrochloride

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Start Date

July 2002

Primary Completion Date

February 2006

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  GOG 0-3

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  SGOT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

          -  Creatinine clearance > 50 mL/min

        Other

          -  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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  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

        Radiotherapy

          -  At least 3 weeks since prior radiotherapy and recovered

        Surgery

          -  Recovered from recent prior surgery

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Barbara A. Goff, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00217555

Organization ID

PSOC 1901

Secondary IDs

PSOC-1901

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Barbara A. Goff, MD, Principal Investigator, University of Washington

Verification Date

September 2010