A Phase I Trial of Capecitabine or Continuous Infusion 5-Fluorouracil in Combination With Weekly Irinotecan and Cisplatin in Patients With Advanced Solid Tumor Malignancies
- This is a Phase I dose escalation study. The dose of drug the patient receives will be
assigned based upon when they enter the study. Since we are looking for the highest
dose of capecitabine or 5-fluorouracil that can be given safely in combination with
cisplatin and irinotecan, not everyone who participates in this study will be receiving
the same amount of the drug.
- There are four parts to this study: 1)Choice of treatment, 2)Evaluation, 3)Chemotherapy
- The patient and the patient's doctor will decide which form of chemotherapy is best for
the patient, either pill form or continuous infusion. Chemotherapy pills
(capecitabine) are given twice per day for 14 days is a row every 3 weeks. Continuous
infusion (5-fluorouracil) is given through a pump 24 hours a day for 14 days every 3
- Prior to initiation to therapy the extent of the patients cancer will be evaluated.
This includes a CT scan, chest x-ray, EKG and bloodwork.
- Patient's will receive chemotherapy for 2 weeks followed by a one week break. This
will constitute one cycle. The medications cisplatin and irinotecan will be given
intravenously on the 1st and 8th day of each cycle. Following the rest period the next
cycle of chemotherapy begins.
- Following 2 cycles of chemotherapy, the patients cancer will be re-evaluated. A CT
scan and bloodwork will be obtained and will be compared to the previous studies.
Treatment will resume if the cancer is the same size or smaller than before and the
patient is tolerating the chemotherapy well. The cancer will be re-evaluated every 2
cycles of chemotherapy.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.
Peter C. Enzinger, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|