Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Marianne Spevak, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT00928642
First received: June 25, 2009
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Drug: imatinib mesylate, Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies

Resource links provided by NLM:


Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • To evaluate 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. [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the 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. [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]
  • To determine the distribution of the overall survival [ Time Frame: Until disease progression; death ] [ Designated as safety issue: No ]
  • To estimate the clinical response rate(partial and complete response as defined under the SWOG criterial) [ Time Frame: until disease progression ] [ Designated as safety issue: No ]
  • To assess the effects of prognostic variables; initial performance status; platinum sensitivity, and mucinous (or clear cell)histology on progression-free survival overall. [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: imatinib mesylate, Gemcitabine
    imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle. Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle
    Other Names:
    • Gleevec
    • Gemzar
Detailed Description:

Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elects to withdraw from the study. All patients will be followed until disease progression or study withdraw. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.

  Eligibility

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT00928642

Locations
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Novartis
Investigators
Principal Investigator: David McCune, MD, MPH Madigan Army Medical Center
  More Information

No publications provided

Responsible Party: Marianne Spevak, Director Regulatory Affairs, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT00928642     History of Changes
Other Study ID Numbers: CSTI571BUS241, MAMC#206126
Study First Received: June 25, 2009
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
ovarian
cancer
peritoneal
endometrioid
mucinous
serous
clear cell

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Gemcitabine
Imatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014