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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00217555
Other study ID # PSOC 1901
Secondary ID PSOC-1901GSK-PSO
Status Completed
Phase Phase 2
First received September 20, 2005
Last updated September 20, 2010
Start date July 2002

Study information

Verified date September 2010
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
gemcitabine hydrochloride

topotecan hydrochloride


Locations

Country Name City State
United States University of Washington School of Medicine Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Goff BA, Holmberg LA, Veljovich D, Kurland BF; Puget Sound Oncology Consortium. Treatment of recurrent or persistent platinum-refractory ovarian, fallopian tube or primary peritoneal cancer with gemcitabine and topotecan: a phase II trial of the Puget Sou — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Toxicity Yes
Primary Response rate No
Primary Quality of life No
Secondary Progression-free survival No
Secondary Overall survival No
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