Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

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

Details

• Lead Sponsor: Emory University
• Collaborator: Novartis
• Treatments: Docetaxel; Imatinib Mesylate

Criteria

Inclusion Criteria:

• This study is for patients with histologically confirmed unresectable gastric adenocarcinoma and who have not received any chemotherapy other than 5-FU for adjuvant therapy either alone or in conjunction with radiation.

Exclusion Criteria:

• Patients may not have received any chemotherapy agents other than 5-FU.

• Patients may not have received 5-FU for for therapy for metastatic gastric cancer.

• Patients must be more than 5 years free of another primary malignancy except: 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.

• Patients must not have Grade III/IV cardiac problems, or any severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).

• Patient must not have had previously received radiotherapy to >/= 25% of the bone marrow, or have had major surgery within 2 weeks prior to study entry

• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.