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A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies

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survival for a period of 5 years, unless consent is withdrawn.

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Until disease progression

Safety Issue:


Principal Investigator

David McCune, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Madigan Army Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

November 2010

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • ovarian
  • cancer
  • peritoneal
  • endometrioid
  • mucinous
  • serous
  • clear cell
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



Madigan Army Medical Center Tacoma, Washington  98431-5048