Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: gemcitabine hydrochloride Drug: topotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
- Toxicity [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Study Start Date: | July 2002 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Barbara A. Goff, MD | University of Washington |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00217555 History of Changes |
| Other Study ID Numbers: | PSOC 1901, PSOC-1901, GSK-PSOC-1901, PSOC-IRB-5320, LILLY-PSOC-1901, CDR0000441309 |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 20, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Gemcitabine Topotecan Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013