Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and bad) the combination may have on the patients cancer.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Aventis Pharmaceuticals; Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Camptothecin; Cisplatin; Docetaxel; Irinotecan

Criteria

Inclusion Criteria:

• Histologically confirmed, incurable esophageal or gastric carcinoma (carcinoma = adenocarcinoma or squamous cell carcinoma)

• Measurable disease > 1cm (longest diameter) by spiral CT scan or > 2cm by other radiographic technique.

• Lesions must be measurable in at least one dimension.

• Bone lesions, ascites and effusions are not measurable.

• Irradiated lesions are not measurable yet lesions arising in previously irradiated fields are measurable.

• Age 18+ years.

• ECOG performance status 0 or 1.

• Life expectancy greater than 12 weeks.

• Adequate bone marrow function.

• Adequate renal function: creatinine equal to or less than 1.5 mg/dl.

• SGOT less than 2.5 x institutional upper limit of normal if alkaline phosphatase is within institutional upper limit of normal.

• Alkaline phosphatase less than 4.0 x upper limit of normal if SGOT is within institutional upper limit of normal.

• For patients with both SGOT and alkaline phosphatase elevations, SGOT must be less than 1.5 x institutional upper limit of normal and alkaline phosphatase must be less 2.5 x institutional upper limit of normal. For patients with liver metastases, however, SGOT may be < 3.0 x institutional upper limit of normal and alkaline phosphatase may be < 5.0 x institutional upper limit of normal as long as the total bilirubin is within the institutional upper limit of normal.

Exclusion Criteria:

• No prior chemotherapy (except as part of pre- or post-operative therapy, completed > 1 year prior to start date of this protocol).

• Patients who have received prior pelvic radiation therapy are ineligible. Other prior radiation therapy, however, is permitted, provided at least 4 weeks have elapsed since completion of this therapy and the initiation of this protocol.

• No myocardial infarction in the past six months.

• No major surgery in the past three weeks.

• No uncontrolled serious medical or psychiatric illness.

• No uncontrolled diarrhea.

• Patients with a peripheral neuropathy > grade 1 will be excluded.

• Women of childbearing potential must have a negative pregnancy test. Men and women of childbearing potential must use adequate contraception.

• No clinically apparent central nervous system metastases or carcinomatous meningitis.

• No other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years.

• Patients with history of severe hypersensitivity to irinotecan, cisplatin, taxotere or drugs formulated with polysorbate 80 must be excluded.