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CompletedNCT00215501Updated Nov 2, 2018

Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies

A Phase 1 interventional study of Capecitabine and 5-Fluorouracil (5-FU) in Solid Tumor, sponsored by Dana-Farber Cancer Institute. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Solid Tumor

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Keywords

  • advanced solid tumor malignancy
  • capecitabine
  • continuous infusion
  • 5-FU
  • irinotecan
  • 5-fluorouracil
  • cisplatin
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 54 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Group A

    Oral capecitabine

    Drug: Capecitabine · Drug: Irinotecan · Drug: Cisplatin

  • Experimental
    Group B

    5-fluorouracil

    Drug: 5-Fluorouracil (5-FU) · Drug: Irinotecan · Drug: Cisplatin

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

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. To make a preliminary assessment of the anti-tumor activity of these combinations.

    Time frame: 2 years

07

Study locations

3 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00215501
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
Responsible party
Peter C. Enzinger, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 22, 2005
Start date
Nov 2001
Primary completion
Sep 2005
Completion
Sep 2008
Last update
Nov 2, 2018

Study contacts

Peter C. Enzinger, MD
principal investigator · Dana-Farber Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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