Solid Tumor
Conditions
Keywords
advanced solid tumor malignancy, capecitabine, continuous infusion, 5-FU, irinotecan, 5-fluorouracil, cisplatin
Brief summary
The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors.
Detailed description
* 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 and 4)Follow-up. * 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 weeks. * 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.
Interventions
DRUGCapecitabine
Orally twice a day for 14 days (dosage will vary)
DRUG5-Fluorouracil (5-FU)
Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary
DRUGIrinotecan
Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
DRUGCisplatin
Intravenously weekly for 2 weeks followed by a one week rest period
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed solid tumor malignancy * 18 years of age or older * Two prior chemotherapy regimens for metastatic disease. Prior chemotherapy must have been completed at least 3 weeks prior to initiation of this protocol. * ECOG performance status of 0,1 or 2 * Neutrophils greater or equal to 1,500/ul * Platelets greater or equal to 100,000/ul * Serum bilirubin less or equal to 1.5 mg/dl * Creatinine clearance greater than 50 ml/min * AST or SGOT less or equl to 3x ULN * Prior radiotherapy is allowable, provided at least 4 weeks have elapsed and the patient has recovered from all therapy related side effects.
Exclusion criteria
* Life expectancy of less than 3 months * Clinically significant cardiac disease or myocardial infarction within past 6 months * Suspicion or documentation of CNS metastases or carcinomatous meningitis * Psychiatric disability judged by the investigator to be clinically significant, precluding informed consent * Known existing coagulopathy and/or requires therapeutic anticoagulants * Uncontrolled diarrhea * Peripheral neuropathy * Major surgery within 3 weeks of the state of the study treatment without complete recovery * Serious, uncontrolled, concurrent infection * Lack of physical integrity of upper gastrointestinal tract or malabsorption syndrome * Prior severe reaction to fluoropyrimidine, irinotecan or cisplatin * Known interstitial pulmonary fibrosis * Known Gilbert's disease * Uncontrolled diabetes mellitus * Organ allograft(s) on immunosuppressive therapy * Pregnant or lactating women * Patients taking valproic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| To make a preliminary assessment of the anti-tumor activity of these combinations. | 2 years |
Countries
United States
Outcome results
None listed