Clinical trial · Interventional
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cancer | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine Intravenous | Drug | Gemcitabine | ALIAS |
| imatinib mesylate by mouth | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Imatinib plus intravenous gemcitabine
- description
- 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.
- interventionNames
- Drug: imatinib mesylate by mouth
- Drug: Gemcitabine Intravenous
Primary outcomes (2)
- measure
- 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.
- timeFrame
- Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available