NCT00054119

Brief Summary

Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2005

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

February 5, 2003

Last Update Submit

July 12, 2017

Conditions

Primary Peritoneal CarcinomaRecurrent Ovarian Carcinoma

Outcome Measures

Primary Outcomes (6)

  • Frequency of objective response

    Up to 6 years

  • Duration of objective response

    Up to 6 years

  • Frequency of observed adverse effects, graded according to CTC version 2.0

    Up to 6 years

  • Severity of observed adverse effects, graded according to CTC version 2.0

    Up to 6 years

  • Survival time for all patients

    Up to 6 years

  • Duration of progression-free interval for all patients

    Up to 6 years

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: CositecanOther: Pharmacological Study

Interventions

CositecanDRUG

Given IV

Also known as: BNP1350, DB 172, Karenitecin
Treatment
Pharmacological StudyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed ovarian epithelial or primary peritoneal cancer
  • Recurrent or persistent disease
  • Platinum-resistant disease
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target)
  • Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No myocardial infarction within the past 6 months
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

cositecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • John Kavanagh

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

January 1, 2003

Primary Completion

September 30, 2005

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)