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

This study is ongoing, but not recruiting participants.
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute Identifier:
First received: September 14, 2005
Last updated: July 8, 2016
Last verified: July 2016
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.

Condition Intervention Phase
Solid Tumor
Drug: Capecitabine
Drug: 5-Fluorouracil (5-FU)
Drug: Irinotecan
Drug: Cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To make a preliminary assessment of the anti-tumor activity of these combinations. [ Time Frame: 2 years ]

Estimated Enrollment: 68
Study Start Date: November 2001
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Oral capecitabine
Drug: Capecitabine
Orally twice a day for 14 days (dosage will vary)
Drug: Irinotecan
Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
Drug: Cisplatin
Intravenously weekly for 2 weeks followed by a one week rest period
Experimental: Group B
Drug: 5-Fluorouracil (5-FU)
Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary
Drug: Irinotecan
Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
Drug: Cisplatin
Intravenously weekly for 2 weeks followed by a one week rest period

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00215501

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Principal Investigator: Peter C. Enzinger, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00215501     History of Changes
Other Study ID Numbers: 01-042
Study First Received: September 14, 2005
Last Updated: July 8, 2016

Keywords provided by Dana-Farber Cancer Institute:
advanced solid tumor malignancy
continuous infusion

Additional relevant MeSH terms:
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017