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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00165464

Collaborator

Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other), Brigham and Women's Hospital (Other), Aventis Pharmaceuticals (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer GE Junction Cancer	Drug: Taxotere Drug: Cisplatin Drug: Irinotecan	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Apr 1, 2009

Outcome Measures

Primary Outcome Measures

To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11). []

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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