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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

Phase 1
18 Years
Open (Enrolling)
Solid Tumor

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Trial Information

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
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

- 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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Peter C. Enzinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

November 2001

Completion Date:

January 2013

Related Keywords:

  • Solid Tumor
  • advanced solid tumor malignancy
  • capecitabine
  • continuous infusion
  • 5-FU
  • irinotecan
  • 5-fluorouracil
  • cisplatin
  • Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617