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Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Safety Issue:

Yes

Principal Investigator

Barbara A. Goff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Federal Government

Study ID:

PSOC 1901

NCT ID:

NCT00217555

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

University of Washington School of MedicineSeattle, Washington  98195