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| Descriptive Information Fields | |||||
| 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Toxicity [ Designated as safety issue: Yes ] Response rate [ Designated as safety issue: No ] Quality of life [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Progression-free survival [ Designated as safety issue: No ] Overall survival [ Designated as safety issue: No ] |
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| Condition † | Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
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| Intervention † | Drug: gemcitabine hydrochloride Drug: topotecan hydrochloride |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | July 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00217555 | ||||
| Organization ID | CDR0000441309 | ||||
| Secondary IDs †† | PSOC-1901, GSK-PSOC-1901, PSOC-IRB-5320, LILLY-PSOC-1901 | ||||
| Study Sponsor † | Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2006 | ||||
| First Received Date † | September 20, 2005 | ||||
| Last Updated Date | July 23, 2008 | ||||