Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036751
First received: May 13, 2002
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded to previous treatment. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of STI571 For The Treatment Of Platinum And Taxane Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete and partial confirmed response) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by NCI Common Toxicity Criteria version 2.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2002
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. Determine the response rates (confirmed, complete, and partial) in patients with platinum- and taxane-refractory stage III or IV ovarian epithelial or primary peritoneal cancer treated with imatinib mesylate.

II. Determine the toxicity of this drug in these patients. III. Correlate, preliminarily, CD117 and platelet-derived growth factor receptor expression levels with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma

    • No mixed Mullerian tumors
    • No borderline ovarian tumors
  • Stage III or IV disease at time of diagnosis by surgical staging
  • Expression of KIT (CD117) and/or platelet-derived growth factor receptor by immunohistochemistry
  • Relapsed within 6 months after completion of or progressed while receiving prior frontline chemotherapy with a platinum (cisplatin or carboplatin) and a taxane(paclitaxel or docetaxel) administered concurrently or sequentially
  • Measurable disease
  • Performance status - Zubrod 0-1
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
  • At least 28 days since prior biologic therapy
  • No concurrent anticancer biologic therapy
  • No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • At least 28 days since prior chemotherapy
  • No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy

    • Retreatment with a platinum agent or with the same taxane as in the frontline regimen is not counted as an additional regimen
  • No concurrent chemotherapy
  • Prior hormonal therapy allowed
  • Recovered from prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy
  • Prior surgical debulking allowed for relapsed disease if measurable disease remains after surgery
  • At least 14 days since prior major surgery
  • Recovered from all prior surgery
  • At least 28 days since prior investigational drugs
  • No concurrent therapeutic doses of warfarin for anticoagulation (heparin or mini-dose warfarin (1 mg/day) allowed)
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036751

Locations
United States, Texas
Southwest Oncology Group (SWOG) Research Base
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: David Alberts Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00036751     History of Changes
Other Study ID Numbers: NCI-2012-02463, SWOG-S0211, U10CA032102, CDR0000069319
Study First Received: May 13, 2002
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014