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

Primary Purpose

Esophageal Cancer, Gastric Cancer, GE Junction Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Taxotere
Cisplatin
Irinotecan
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Gastric Cancer, GE Junction, Cisplatin, Taxotere, CPT-11, Irinotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Faulkner Hospital

Outcomes

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.

Full Information

First Posted
September 9, 2005
Last Updated
April 24, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00165464
Brief Title
Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer
Official Title
A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Aventis Pharmaceuticals

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer, GE Junction Cancer
Keywords
Esophageal Cancer, Gastric Cancer, GE Junction, Cisplatin, Taxotere, CPT-11, Irinotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Taxotere
Intervention Description
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
Intervention Name(s)
Cisplatin
Intervention Description
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
Intervention Name(s)
Irinotecan
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).
Secondary Outcome Measure Information:
Title
To assess the duration of response and overall survival of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan.
Title
To assess the toxicity of this combination in esophageal or gastric carcinoma.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C. Enzinger, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Faulkner Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19139178
Citation
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.
Results Reference
result

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

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