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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

topotecan hydrochloride

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring fallopian tube cancer, peritoneal cavity cancer, recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Escalating Cohorts

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose

Secondary Outcome Measures

Full Information

NCT ID

NCT00287859

First Posted

February 6, 2006

Last Updated

November 27, 2017

Sponsor

Masonic Cancer Center, University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT00287859

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Withdrawn due to low accrual

Study Start Date

August 2004 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escalating Cohorts

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

topotecan hydrochloride

Other Intervention Name(s)

Hycamtin(R)

Intervention Description

intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.

Primary Outcome Measure Information:

Title

Maximum tolerated dose

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Levi S. Downs, MD

Organizational Affiliation

Masonic Cancer Center, University of Minnesota

Official's Role

Study Chair

Facility Information:

Facility Name

University of Minnesota Cancer Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial