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A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer



- Determine the antitumor activity of topotecan, in terms of frequency and duration of
tumor response, in patients with recurrent platinum-sensitive ovarian epithelial,
fallopian tube, or primary peritoneal cancer.

- Determine the nature and degree of toxicity of this regimen in these patients.


- Determine the duration of progression-free survival and overall survival in patients
treated with these regimens.

- Determine the effects of prognostic variables (i.e., initial performance status, age,
and mucinous or clear cell histology) in patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued
for this study within 15-30 months.

Inclusion Criteria


- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal

- Recurrent disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- At least 1 target lesion not in a previously irradiated field

- Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease
containing carboplatin, cisplatin, or other organoplatinum compound

- Initial treatment may have included high-dose, consolidation, or extended
therapy administered after surgical or non-surgical assessment

- Patients who have not received prior paclitaxel may receive a second regimen
that includes paclitaxel

- Platinum-sensitive disease

- Treatment-free interval* without clinical evidence of progressive disease for >
6 months after prior response to a platinum-based regimen NOTE: *Non-platinum
maintenance or consolidation therapy is not included in calculation of the
treatment-free interval

- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
protocol for the same patient population)



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ 1.5 times ULN

- Creatinine clearance > 40 mL/min


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No sensory or motor neuropathy > grade 1

- No active infection requiring antibiotics

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer


Biologic therapy

- At least 3 weeks since prior biologic or immunologic agents for the malignancy

- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal
antibodies, cytokines, or small molecule inhibitors of signal transduction) for
recurrent disease

- No concurrent cytokines during the first course of study treatment

- No concurrent pegfilgrastim


- See Disease Characteristics

- See Biologic therapy

- Recovered from prior chemotherapy

- No other prior cytotoxic chemotherapy for recurrent disease, including retreatment
with initial chemotherapy regimen

- No prior topotecan

Endocrine therapy

- At least 1 week since prior hormonal therapy for the malignancy

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- Recovered from prior radiotherapy

- No prior radiotherapy to > 25% of marrow-bearing areas


- Recovered from prior surgery


- At least 3 weeks since other prior therapy for the malignancy

- No prior anticancer therapy that would preclude study treatment

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Safety Issue:


Principal Investigator

Thomas J. Herzog, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2005

Completion Date:

Related Keywords:

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



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