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

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer; Gastric Cancer; GE Junction Cancer

Intervention: Taxotere (Drug); Cisplatin (Drug); Irinotecan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Peter C. Enzinger, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States

Faulkner Hospital, Boston, Massachusetts 02130, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Additional Information

Starting date: August 2001
Last updated: April 24, 2009

Page last updated: August 23, 2015

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