Esophageal Cancer, Gastric Cancer, GE Junction Cancer
Conditions
Keywords
Esophageal Cancer, Gastric Cancer, GE Junction, Cisplatin, Taxotere, CPT-11, Irinotecan
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 combination may have on the patients cancer.
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, intravenous hydration and anti-emetic therapy prior to each treatment. * A physical exam and bloodwork will be done each week of the treatment and every 2 cycles, reassessment of the tumor by the same imaging method to determine the baseline size will be conducted. * Patients will remain on the study unless disease progression or intolerable toxicity occur.
Interventions
DRUGTaxotere
Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
DRUGCisplatin
Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
DRUGIrinotecan
Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
Sponsors
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Aventis Pharmaceuticals
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the duration of response and overall survival of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan. | — |
| To assess the toxicity of this combination in esophageal or gastric carcinoma. | 4 years |
Countries
United States
Outcome results
None listed