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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165464
• Other study ID #: 01-140
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: April 24, 2009
• Start date: August 2001
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2009
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• GE Junction Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Aventis Pharmaceuticals, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).		TBD	No
Secondary	To assess the duration of response and overall survival of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan.		TBD	No
Secondary	To assess the toxicity of this combination in esophageal or gastric carcinoma.		4 years	Yes