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Phase II Evaluation of Three-Day Topotecan (NSC 609699) in Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

Phase 2
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

Phase II Evaluation of Three-Day Topotecan (NSC 609699) in Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

OBJECTIVES: I. Determine the antitumor activity of topotecan in patients with recurrent
platinum sensitive ovarian epithelial or primary peritoneal cancer. II. Determine the nature
and degree of toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-3. Treatment continues
every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are
followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial or primary
peritoneal carcinoma Bidimensionally measurable disease (ascites and pleural effusions not
considered measurable) Platinum sensitive (defined as treatment free interval following
response to platinum of greater than 6 months) One prior platinum based chemotherapy
regimen for management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound required

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) SGOT and alkaline phosphatase no greater that 2.5 times ULN Renal: Creatinine
no greater than 1.5 times ULN Other: No active infection requiring antibiotics No
neuropathy greater than grade 1 Not pregnant Negative pregnancy test Fertile patients must
use effective contraception No prior malignancy within past 5 years except nonmelanoma
skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic or
immunologic agents Chemotherapy: See Disease Characteristics Recovered from prior
chemotherapy Patients with no prior paclitaxel therapy may receive second regimen that
includes paclitaxel No other prior or concurrent cytotoxic chemotherapy for recurrent or
persistent disease, including retreatment with initial chemotherapy regimens No prior
topotecan Endocrine therapy: At least one week since prior hormonal therapy for malignant
tumor Prior and concurrent hormone replacement therapy allowed Radiotherapy: No prior or
concurrent radiotherapy to target sites No prior radiotherapy to greater than 25% of bone
marrow Recovered from prior radiotherapy Surgery: Recovered from prior surgery Other: No
prior cancer treatment that contraindicates study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



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