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Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of weekly topotecan in patients with progressive
or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
and a poor performance status.

Secondary

- Estimate the response rate of women with poor performance status for use in future
clinical trials.

OUTLINE: This is a dose-escalation study.

Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.
Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. A total of 6 patients will be treated at
the MTD.

Patients are followed periodically for up to 2 years.


Inclusion Criteria:



- Histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal
cavity cancer

- Progressive or recurrent disease

- Received ≥ 1 prior course of chemotherapy

- Measurable or evaluable disease OR disease assessable by CA 125, defined as CA 125 >
normal that has increased over 2 readings > 14 days apart

- Karnofsky performance status 10-50%

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

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 mg/dL

- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 times ULN

- SGOT ≤ 3 times ULN

- Life expectancy ≥ 12 weeks

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use accepted and effective non-hormonal contraception

Exclusion Criteria:

- Other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin
cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy

- Septicemia, severe infection, or acute hepatitis

- Severe gastrointestinal bleeding, defined as requiring a blood transfusion or
hospitalization

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:

Yes

Principal Investigator

Levi S. Downs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2004LS039

NCT ID:

NCT00287859

Start Date:

August 2004

Completion Date:

December 2006

Related Keywords:

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

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455