Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer

NCT00928642 | Completed Phase 2 Results

• 2 other identifiers: CSTI571BUS241MAMC#206126
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study will continue as long as the patient's tumors shrink or remain stable and as long as the patient is able to tolerate the study drug. The follow-up portion of the study will last for 5 years.

Conditions

Ovarian Cancer; Primary Peritoneal Cancer

Keywords

ovarian; cancer; peritoneal; endometrioid; mucinous; serous; clear cell

Outcome Measures

Primary Outcomes (2)

• The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.

  Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as \> 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.

  Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.

• To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria

  Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria

  Until disease progression or unacceptable toxicity

Secondary Outcomes (4)

• Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.

  Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified

• To Determine the Distribution of the Overall Survival

  Until death

• To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)

  until disease progression or unacceptable toxicity

• To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.

  Until disease progression

Study Arms (1)

Oral Imatinib plus intravenous gemcitabine

EXPERIMENTAL

All research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle. All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. . All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or progressed after prior chemotherapy.

Drug: imatinib mesylate by mouth; Drug: Gemcitabine Intravenous

Interventions

imatinib mesylate by mouth DRUG

imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle.

Also known as: Gleevec

Oral Imatinib plus intravenous gemcitabine

Gemcitabine Intravenous DRUG

Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle

Also known as: Gemzar

Oral Imatinib plus intravenous gemcitabine

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or greater
• Histologically documented diagnosis of ovarian cancer or primary peritoneal cancer. Histological subtypes include: mucinous tumor, serous tumor, endometrioid tumor, and other histologies including clear cell and undifferentiated epithelial tumors.
• At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria) or other response assessment criteria, as appropriate.
• Patients must have relapsed after receiving at least one prior platinum-based chemotherapy.
• Performance status of 0, 1, 2, (ECOG)
• Adequate end organ function: Total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 UNL, creatinine \< 1.5 x UNL, ANC \> 1.5 x 109/L, platelets \> 100 x 109/L.
• Patients will most likely have had their ovaries removed at the time off initial surgery. If any subjects are of childbearing potential at the time of entry, they must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Subjects of reproductive potential must agree to employ and effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of the study drug.
• Written, voluntary informed consent.
• Patients must be eligible for care at a military medical treatment facility.

You may not qualify if:

• Patient has received prior treatment with Gemzar.
• Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
• Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is neither currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
• Patient with Grade III/IV cardiac problems as defined but the New York Heart Association Criteria.
• Patients who are pregnant or breast-feeding.
• Patient has a severe and/or uncontrolled medical disease (i,e. uncontrolled diabetes, uncontrolled chronic renal disease, or active uncontrolled infection).
• Patient has a known untreated or progressive brain metastasis.
• Patient has known chronic liver diseases (i.e. chronic active hepatitis, and cirrhosis.
• Patient has a known diagnosis of human immunodeficiency virus (HIV infection ).
• Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing..
• Patient previously received radiotherapy to greater than or equal to 25% of the bone marrow.
• Patient had a major surgery within 2 weeks prior to study entry.
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Novartis: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

Imatinib Mesylate; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Limitations and Caveats

This study was terminated due to a combination of poor accrual and lack of evidence of benefit.

Results Point of Contact

• Title: COL David E. McCune, MD, MC
• Organization: Madigan Army Medical Center

david.e.mccune.mil@mail.mil

253-968-1155

Study Officials

• David McCune, MD, MPH

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 21, 2014
• Results First Posted: October 21, 2014

Record last verified: 2014-10

Locations

US (1)