Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
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
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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:
Detailed Description:
-
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165464
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Faulkner Hospital | |
| Boston, Massachusetts, United States, 02130 | |
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 Diseases Esophageal Neoplasms Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Stomach Diseases Irinotecan |
Docetaxel Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013