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

NCT ID: NCT00165464

Last Updated: 2009-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2009-04-30

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.

Conditions

Esophageal Cancer; Gastric Cancer; GE Junction Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Taxotere

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.

Intervention Type: DRUG

Cisplatin

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.

Intervention Type: DRUG

Irinotecan

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Dana-Farber Cancer Institute/Brigham and Women's Hospital

Principal Investigators

Peter C. Enzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Faulkner Hospital

Boston, Massachusetts, United States

Countries

United States

References

Enzinger PC, Ryan DP, Clark JW, Muzikansky A, Earle CC, Kulke MH, Meyerhardt JA, Blaszkowsky LS, Zhu AX, Fidias P, Vincitore MM, Mayer RJ, Fuchs CS. Weekly docetaxel, cisplatin, and irinotecan (TPC): results of a multicenter phase II trial in patients with metastatic esophagogastric cancer. Ann Oncol. 2009 Mar;20(3):475-80. doi: 10.1093/annonc/mdn658. Epub 2009 Jan 12.

Reference Type: RESULT

PMID: 19139178 (View on PubMed)

Other Identifiers

01-140

Identifier Type: -

Identifier Source: org_study_id