Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00506779
First received: July 23, 2007
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Cancer |
Drug: Imatinib Mesylate Drug: Paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Gleevec/Taxol in Patients With Newly Diagnosed Stage IIIC or IV or Recurrent (Any Stage) Uterine Papillary Serous Carcinoma (UPSC) |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) of imatinib mesylate in combination with fixed dose paclitaxel [ Time Frame: Evaulated with each 3 week cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 65 |
| Study Start Date: | December 2003 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paclitaxel + Imatinib Mesylate
Phase I, Phase II (Arm 2) = Paclitaxel + Imatinib Mesylate
|
Drug: Imatinib Mesylate
Phase I = 400 mg by mouth daily Phase II (Arm 2) = 400 mg by mouth daily Other Names:
Drug: Paclitaxel
175 mg/m^2 by vein Over 3 Hours Every 21 Days
Other Name: Taxol
|
|
Experimental: 2
Phase II, (Arm 1) = Paclitaxel
|
Drug: Paclitaxel
175 mg/m^2 by vein Over 3 Hours Every 21 Days
Other Name: Taxol
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Patients may not receive concurrent radiotherapy while participating in this protocol.
- Patients may have measurable or non-measurable disease.
- Patients may have mixed endometrioid or clear cell components in addition to the serous histology.
- 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.
- 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.
- Patients must have an adequate renal function as documented by serum creatinine of </=2.0 mg/dl.
- Patients must have adequate hepatic function as documented by a serum bilirubin </=1.5mg/dl, regardless of whether patients have liver involvement secondary to tumor. Alanine aminotransferase (SGPT) and aspartate aminotransferase (SGOT) must be </=2.5x institutional upper limit of normal unless the liver is involved with tumor, in which case levels must be </=5x institutional upper limit of normal.
- Zubrod performance status of 0, 1, or 2.
- Patients should not have received prior chemotherapy or radiation (except palliative radiation) within the last 30 days.
- Patients must have signed informed consent indicating that they are aware of the investigational nature of this study.
Exclusion Criteria:
- Patients who have previously received imatinib mesylate or taxanes.
- Patients with any active or uncontrolled systemic infection, including known HIV infection.
- Patients with psychiatric disorders that would interfere with consent or follow-up.
- Patients with NYHA Class III/IV congestive heart failure, unstable angina or a history of myocardial infarction within the previous 6 months.
- 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.
- Oxygen-dependent lung disease.
- Patients in whom corticosteroids are contraindicated.
- Uncontrolled severe hypertension or uncontrolled diabetes mellitus.
- Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
- Patients with any form of chronic liver disease.
- Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
- 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.
- Patients with a deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry.
- Patients who are receiving therapeutic doses of warfarin or any blood thinning agent.
- Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.
- Pregnant or lactating women. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506779
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | David M. Gershenson, MD,BA | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00506779 History of Changes |
| Other Study ID Numbers: | GYN03-0177 |
| Study First Received: | July 23, 2007 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Uterine Papillary Serous Carcinoma Uterine Cancer UPSC Taxol |
Paclitaxel Gleevec Imatinib Mesylate STI571 |
Additional relevant MeSH terms:
|
Carcinoma Uterine Neoplasms Cystadenocarcinoma, Serous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Cystadenocarcinoma Adenocarcinoma |
Neoplasms, Cystic, Mucinous, and Serous Paclitaxel Imatinib Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013