NCT00041041

Brief Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have persistent or recurrent ovarian epithelial or primary peritoneal cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 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

June 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

February 20, 2013

Status Verified

January 1, 2013

Enrollment Period

4.6 years

First QC Date

July 8, 2002

Last Update Submit

February 19, 2013

Conditions

Primary Peritoneal Cavity CancerRecurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    At 6 months

  • Frequency and severity of adverse effects as assessed by CTC

    Up to 7 years

Secondary Outcomes (4)

  • Duration of overall survival

    Up to 7 years

  • Duration of progression-free survival

    Up to 7 years

  • Frequency of clinical response (partial and complete response)

    Up to 7 years

  • Prognostic variables: initial performance status, age, platinum sensitivity, and mucinous (or clear cell) histology

    Baseline

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylateOther: laboratory biomarker analysis

Interventions

imatinib mesylateDRUG

Given PO

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (imatinib mesylate)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Recurrent or persistent disease
  • At least 1 unidimensionally measurable target lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Tumors within a previously irradiated field considered nontarget lesions
  • At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required
  • Initial treatment may include high-dose, consolidation, or extended therapy
  • Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen
  • Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen
  • Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
  • Performance status - GOG 0-2 (if patient has received one prior treatment regimen)
  • Performance status - GOG 0-1 (if patient has received two prior treatment regimens)
  • 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)
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Russell Schilder

    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
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

June 1, 2002

Primary Completion

January 1, 2007

Last Updated

February 20, 2013

Record last verified: 2013-01

Locations

US(1)