Gleevec Study for Patients With Ovarian Cancer

NCT00510653 | Completed Phase 2 Results

• 1 other identifier: ID01-707
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To determine the efficacy of Gleevec in patients with recurrent platinum-resistant, taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor (PDGRF), or ABL.
2. 2.To determine the nature and degree of toxicity of Gleevec in this cohort of patients.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer; Recurrent Platinum-Resistant; Taxane-Resistant; Epithelial Ovarian Cancer; Imatinib Mesylate; Gleevec; STI571; Protein tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): \>/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or \> increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.

  6 weeks with re-evaluation every 6 weeks or until disease progression

Study Arms (1)

Imatinib Mesylate

EXPERIMENTAL

600 mg/day orally for 6 Weeks

Drug: Imatinib Mesylate

Interventions

Imatinib Mesylate DRUG

600 mg by mouth daily for 6 Weeks

Also known as: Imatinib, Gleevec, STI571, NSC-716051

Imatinib Mesylate

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed metastatic epithelial ovarian, primary peritoneal cancer, or fallopian tube cancer previously treated with a platinum/taxane-containing regimen. Patients may have either low-grade or high-grade recurrent epithelial tumors.
• Patients with high-grade tumors must be platinum/taxane resistant, as defined by: progression of disease while on a first-line platinum/taxane regimen or tumor progression within 6 months of completion of a platinum/taxane regimen.
• Patients with high-grade tumors may have failed no more than 4 prior chemotherapy regimens. All taxane/platinum therapies will be counted as one regimen.
• Patients with low-grade tumors may have failed unlimited prior therapies.
• Patients' tumor tissue must express one or more of the following biomarkers: c-KIT, PDGFR or ABL. Positivity will be defined as 2+ or 3+ on immunohistochemical staining.
• All patients must have measurable disease. Measurable disease is defined as lesions which can be measured by physical examination or by means of imaging techniques. Ascites and pleural effusions are not to be considered measurable disease. An elevated serum CA 125 level without associated measurable tumor is not to be considered measurable disease.
• Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of \> 1,500/Fl, a hemoglobin level of = 9.0 gm/dL and a platelet count of \> 100,000/Fl.
• Patients must have adequate renal function as documented by a serum creatinine \<2.0 mg/dL.
• Patients must have adequate hepatic function as documented by a serum bilirubin \<1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase (SGOT) must be \< 3\* institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be \< 5\* institutional upper limit of normal.
• Patients must have an estimated life expectancy of 12 weeks or greater.
• Zubrod performance status of 0, 1, or 2.
• Patients must be older than age 18.
• Patients must have signed an approved informed consent.

You may not qualify if:

• Patients who have previously received Gleevec.
• Patients with any active or uncontrolled infection, including known HIV infection.
• Patients with psychiatric disorders that would interfere with consent or follow-up.
• Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
• Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
• Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
• Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible.
• Patients with any other severe concurrent disease which in the judgment of the investigator, would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
• Patients with a deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry.
• Patients who are receiving warfarin.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David Gershenson, MD / Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• David Gershenson, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 2, 2007
• Study Start: March 1, 2002
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 23, 2013
• Results First Posted: August 23, 2013

Record last verified: 2013-06

Locations

US (1)