Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00041041
First received: July 8, 2002
Last updated: February 19, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent 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 Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by CTC [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Duration of progression-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Frequency of clinical response (partial and complete response) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Prognostic variables: initial performance status, age, platinum sensitivity, and mucinous (or clear cell) histology [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2002
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate)
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 mesylate
Given PO
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the cytostatic, anti-tumor activity of Gleevec (Imatinib Mesylate) through the probability of surviving progression-free for at least 6 months in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma receiving Gleevec.

II. To determine the frequency and severity of adverse effects of Gleevec in this cohort of patients as assessed by CTC.

SECONDARY OBJECTIVES:

I. To determine the distribution of the overall survival. II. To determine the distribution of progression-free survival. III. To estimate the clinical response rate (partial and complete response as defined under the RECIST criteria).

IV. To assess the effects of prognostic variables: initial performance status, platinum sensitivity, and mucinous (or clear cell) histology).

TERTIARY OBJECTIVES:

I. To determine the levels of expression of c-KIT and its ligand, stem cell factor (SCF) in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.

II. To determine the levels of expression of platelet derived growth factor receptor (PDGFR) and its ligand PDGF in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.

III. To determine the levels of expression of AKT2 and its activated form, phospho-AKT2, in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.

OUTLINE: This is a multicenter study.

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • SGOT/SGPT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No active infection requiring antibiotics
  • No greater than grade 1 sensory and motor neuropathy
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No signs or symptoms of bowel dysfunction
  • At least 3 weeks since prior immunologic therapy directed at the malignant tumor
  • No concurrent biologic therapy or immunotherapy for the malignant tumor
  • Recovered from prior chemotherapy
  • No prior noncytotoxic chemotherapy for persistent or recurrent disease
  • One additional cytotoxic regimen for persistent or recurrent disease allowed
  • No concurrent chemotherapy for the malignant tumor
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • No concurrent therapeutic corticosteroids
  • No concurrent anticancer hormonal therapy
  • Concurrent hormone replacement therapy allowed
  • Recovered from prior radiotherapy
  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • No concurrent anticancer radiotherapy
  • Recovered from recent prior surgery
  • At least 3 weeks since other prior therapies directed at the malignant tumor
  • No prior imatinib mesylate
  • No prior anticancer therapy that would preclude study participation
  • No concurrent therapeutic anticoagulation with warfarin
  • No other concurrent investigational drugs
  • No concurrent amifostine or other protective reagents
  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: NCT00041041

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Russell Schilder Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041041     History of Changes
Other Study ID Numbers: NCI-2012-02473, GOG-0170E, U10CA027469, CDR0000069438
Study First Received: July 8, 2002
Last Updated: February 19, 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 28, 2014