Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor

NCT00039585 | Completed Phase 2

• 3 other identifiers: CDR0000069403NCI-02-C-0190NCI-5672A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer, or ovarian low malignant potential tumor.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer; borderline ovarian surface epithelial-stromal tumor

Outcome Measures

Primary Outcomes (1)

• Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks

Secondary Outcomes (5)

• Corr. of biochem. modulation of signal transduction pathways downstream of platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinase by tumor lysate microarray analysis in biopsy tissue with patient outcome at baseline and at 4 wks

• Correlation of PDGFR and c-kit expression with response and outcome in patients with epithelial ovarian cancer as measured by tumor microarray analysis on biopsy tissue at baseline and at 4 weeks

• Antiangiogenic activity as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks

• Collateral receptor tyrosine kinase inhibition as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks

• Prediction of response and/or toxicity as measured by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF) proteomics and Artificial Intelligence bioinformatics on serum samples at baseline and every 4 wks

Interventions

imatinib mesylate DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer OR * Histologically confirmed ovarian low malignant potential tumor with invasive recurrence * Relapsed after and/or refractory to platinum- and taxane-based chemotherapy * Patients in first relapse after a disease-free interval of more than 1 year are eligible * Measurable disease outside prior radiation field * Availability of a sentinel lesion that is adequate for core biopsy through percutaneous biopsy or simple laparoscopic means * Patients with clinical evidence of CNS involvement (abnormal clinical examination) must have a negative CT scan with contrast or MRI of the brain * No large volume ascites or pleural effusion PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Hemoglobin at least 9.0 g/dL (independent of epoetin alfa or transfusion) * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No myocardial infarction or unstable dysrhythmia within the past 6 months * No congestive heart failure (CHF), including CHF that may be compensated with furosemide Other: * No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer * No active infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study completion * Concurrent residual, stable, grade 2 or lower peripheral neuropathy allowed at the discretion of the principal investigator (PI) PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior signal transduction therapy Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or carboplatin) Endocrine therapy: * At least 4 weeks since prior hormonal therapy Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * Recovered from prior anticancer therapy * At least 1 week since prior antibiotics * No more than 4 prior anticancer regimens * No concurrent ketoconazole, itraconazole, erythromycin, or clarithromycin * No concurrent therapeutic warfarin * Patients who can be safely converted over to low molecular weight heparin are eligible * No concurrent grapefruit or grapefruit juice * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent alternative or complementary therapies or over-the-counter agents unless approved by the PI * Concurrent medications that may alter the metabolism of imatinib mesylate and lead to potential toxicity are allowed at the discretion of the PI

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892-1906, United States

Location

Related Publications (1)

• Hussain M, Kotz H, Minasian L, et al.: Occurrence of ascites secondary to STI571 in ovarian cancer patients . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-880, 2003.

  RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Elise C. Kohn, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

• Virginia Kwitkowski, MS, RN, CS, CRNP

  National Cancer Institute (NCI)

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: February 1, 2006
• Last Updated: April 30, 2015

Record last verified: 2007-02

Locations

US (2)