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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

September 9, 2005
April 24, 2009
August 2001
March 2005   (final data collection date for primary outcome measure)
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 ]
To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).
Complete list of historical versions of study NCT00165464 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer
A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer

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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • GE Junction Cancer
  • 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.
Not Provided
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. Epub 2009 Jan 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
April 2009
March 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00165464
01-140
Not Provided
Peter C. Enzinger, MD, Dana-Farber Cancer Institute/Brigham and Women's Hospital
Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Aventis Pharmaceuticals
Principal Investigator: Peter C. Enzinger, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP