Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Sanofi-Aventis
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00139243
First received: August 29, 2005
Last updated: June 2, 2008
Last verified: June 2008
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Purpose
The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Cell Carcinoma Carcinoma of Head and/or Neck |
Drug: Taxotere Drug: Cisplatin Drug: 5-Fluorouracil Drug: Leucovorin |
Phase 1 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 I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
Secondary Outcome Measures:
- To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
- to obtain preliminary information about the effectiveness of the drug combination.
| Estimated Enrollment: | 30 |
| Study Start Date: | October 1997 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
- Patients will be premedicated at home with dexamethasone and leucovorin.
- On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
- During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
- At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
- After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic documentation of squamous cell carcinoma of head and neck
- Patients will previously untreated stage III or IV squamous cell carcinoma.
- Patients with locally recurrent disease after surgery.
- Life expectancy of longer than 3 months.
- Kidney function: 1.5 or a 24 hour creatinine clearance of > 30ml/min
- Liver function: SGOT < 1.5 X upper normal limit and alkaline phosphatase of < 2.5 X upper normal limit.
- WBC greater than or equal to 4,000/mm
- Platelet count greater than or equal to 100,000/mm
- Hemoglobin greater than or equal to 10gm/dl
- Patients of child-bearing age must use effective methods of contraception.
Exclusion Criteria:
- Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
- Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
- Pregnant or breast-feeding women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139243
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Sanofi-Aventis
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Marshall Posner, MD | Dana-Farber Cancer Institute |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00139243 History of Changes |
| Other Study ID Numbers: | 97-130 |
| Study First Received: | August 29, 2005 |
| Last Updated: | June 2, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
squamous cell carcinoma Taxotere carcinoma of head/neck |
Cisplatin 5-Fluorouracil Leucovorin |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Docetaxel Cisplatin Fluorouracil Leucovorin Levoleucovorin Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on October 16, 2012
