Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Objectives:

• To determine the maximum tolerated dose (MTD) of imatinib mesylate in combination with fixed dose paclitaxel in patients with stage IIIC, IV or recurrent uterine papillary serous carcinoma.

• To determine the nature and degree of toxicity of imatinib mesylate and paclitaxel in this cohort of patients.

• To determine the efficacy of imatinib mesylate and paclitaxel in patients with stage IIIC, IV or recurrent uterine papillary serous carcinoma whose tumor expresses either c-Kit, PDGFR or abl.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Imatinib Mesylate; Paclitaxel

Criteria

Inclusion Criteria:

1. Histologically confirmed newly diagnosed (stage IIIC or IV) or recurrent (any stage) uterine papillary serous carcinoma. Patients with recurrent disease may not have been treated with taxanes in the past.

2. Patients may not receive concurrent radiotherapy while participating in this protocol.

3. Patients may have measurable or non-measurable disease.

4. Patients may have mixed endometrioid or clear cell components in addition to the serous histology.

5. Patients' tumor tissue must express one or more of the following biomarkers: c-Kit, PDGFR-B, or Abl. Positivity will be defined as 2+/3+ intensity in at least 10% of the tumor.

6. Patients must have pretreatment granulocyte count (i.e. segmented neutrophils and bands) of >/= 1,500/Fl, a hemoglobin level of >/= 9.0 gm/dl, and a platelet count of >/= 100,000/Fl.

7. Patients must have an adequate renal function as documented by serum creatinine of

8. Patients must have adequate hepatic function as documented by a serum bilirubin Alanine aminotransferase (SGPT) and aspartate aminotransferase (SGOT) must beinstitutional upper limit of normal unless the liver is involved with tumor, in which case levels must be

9. Zubrod performance status of 0, 1, or 2.

10. Patients should not have received prior chemotherapy or radiation (except palliative radiation) within the last 30 days.

11. Patients must have signed informed consent indicating that they are aware of the investigational nature of this study.

Exclusion Criteria:

1. Patients who have previously received imatinib mesylate or taxanes.

2. Patients with any active or uncontrolled systemic infection, including known HIV infection.

3. Patients with psychiatric disorders that would interfere with consent or follow-up.

4. Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or a history of myocardial infarction within the previous 6 months.

5. 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 three years.

6. Oxygen-dependent lung disease.

7. Patients in whom corticosteroids are contraindicated.

8. Uncontrolled severe hypertension or uncontrolled diabetes mellitus.

9. Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.

10. Patients with any form of chronic liver disease.

11. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.

12. 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.

13. Patients with a deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry.

14. Patients who are receiving therapeutic doses of warfarin or any blood thinning agent.

15. Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.

16. Pregnant or lactating women. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.