NCT00287859

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

February 6, 2006

Last Update Submit

November 27, 2017

Conditions

Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer

Keywords

fallopian tube cancerperitoneal cavity cancerrecurrent ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

Study Arms (1)

Escalating Cohorts

EXPERIMENTAL

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

Interventions

topotecan hydrochlorideDRUG

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

Also known as: Hycamtin(R)
Escalating Cohorts

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Levi S. Downs, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

August 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)