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

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Aventis Pharmaceuticals
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165464
First received: September 9, 2005
Last updated: April 24, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Esophageal Cancer
Gastric Cancer
GE Junction Cancer
Drug: Taxotere
Drug: Cisplatin
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11). [ Time Frame: TBD ] [ Designated as safety issue: No ]

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. [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • To assess the toxicity of this combination in esophageal or gastric carcinoma. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: August 2001
Study Completion Date: April 2009
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    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.
    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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165464

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Aventis Pharmaceuticals
Investigators
Principal Investigator: Peter C. Enzinger, MD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Peter C. Enzinger, MD, Dana-Farber Cancer Institute/Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00165464     History of Changes
Other Study ID Numbers: 01-140
Study First Received: September 9, 2005
Last Updated: April 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Esophageal Cancer
Gastric Cancer
GE Junction
Cisplatin
Taxotere
CPT-11
Irinotecan

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Cisplatin
Docetaxel
Irinotecan
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014