Status:
COMPLETED
Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 combin...
Detailed Description
* Taxotere, cisplatin and irinotecan will be administered to the patient once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks). * Patients will also receive corticosteroids, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00165464
Start Date
August 1 2001
End Date
April 1 2009
Last Update
April 28 2009
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Faulkner Hospital
Boston, Massachusetts, United States, 02130