Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

• ClinicalTrials.gov Identifier: NCT00287859
• Recruitment Status: Terminated
• First Posted: February 7, 2006
• Last Update Posted: November 29, 2017
• Sponsor: Masonic Cancer Center, University of Minnesota
• Information provided by: Masonic Cancer Center, University of Minnesota

Study Description

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.

Condition or disease	Intervention/treatment	Phase
Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer	Drug: topotecan hydrochloride	Phase 1

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
• Study Start Date: August 2004
• Actual Primary Completion Date: December 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

Arm

Intervention/treatment

Experimental: Escalating Cohorts; 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.

Drug: topotecan hydrochloride; intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.; Other Name: Hycamtin(R)

Outcome Measures

Primary Outcome Measures :

1. Maximum tolerated dose

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

• Study Chair: Levi S. Downs, MD; Masonic Cancer Center, University of Minnesota

More Information

• Responsible Party: Levi Downs, Jr, MD, Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT00287859
• Other Study ID Numbers: 2004LS039; UMN-WCC-39 ( Other Identifier: Women's Cancer Center, University of Minnesota )
• First Posted: February 7, 2006
• Last Update Posted: November 29, 2017
• Last Verified: November 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:

fallopian tube cancer; peritoneal cavity cancer; recurrent ovarian epithelial cancer

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Topotecan; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents