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 Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Barbara A. Goff, MD, Principal Investigator, University of Washington
Verification Date
September 2010