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Irinotecan and Capecitabine in Treating Patients With Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: Albert Einstein College of Medicine of Yeshiva University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003867
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.


Condition Intervention Phase
Cancer
Drug: capecitabine
Drug: irinotecan hydrochloride
Phase I

Genetics Home Reference related topics:   Benign Tumors   Cancer  

MedlinePlus related topics:   Anal Cancer   Breast Cancer   Cancer   Carcinoid Tumors   Esophageal Cancer   Esophagus Disorders   Pancreatic Cancer  

ChemIDplus related topics:   Irinotecan   Irinotecan hydrochloride   Capecitabine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   March 1999

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response and/or toxic effects in these patients.

OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed solid tumors, including but not limited to breast, gastrointestinal, and unknown primary cancer that is refractory to standard therapy or for which no standard therapy exists No known bone marrow involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 OR WBC at least 3,500/mm3 AND Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL No known Gilbert's syndrome No other significant hepatic disease requiring medication Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease requiring medication Other: Not pregnant or nursing Fertile patients must use effective contraception No other significant medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior colony stimulating factor and other cytokines active on bone marrow Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No prior or concurrent irinotecan and fluorouracil therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Recovered from prior major surgery

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003867

Locations
United States, New York
Albert Einstein Comprehensive Cancer Center    
      Bronx, New York, United States, 10461

Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University

Investigators
Study Chair:     Sridhar Mani, MD     Albert Einstein College of Medicine of Yeshiva University    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067031, AECM-1199903068, NCI-V99-1541
First Received:   November 1, 1999
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00003867
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer  
stage IV colon cancer  
stage IV breast cancer  
stage IIIA breast cancer  
recurrent breast cancer  
stage III gastric cancer  
stage IV gastric cancer  
recurrent gastric cancer  
stage IIIB breast cancer  
stage II pancreatic cancer  
stage III pancreatic cancer
recurrent pancreatic cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage IV anal cancer
recurrent anal cancer
stage II esophageal cancer
stage III esophageal cancer

Study placed in the following topic categories:
Leiomyosarcoma
Pancreatic Neoplasms
Esophageal Neoplasms
Irinotecan
Liver neoplasms
Liver Neoplasms
Stomach Neoplasms
Lymphoma
Esophageal neoplasm
Rectal cancer
Hepatocellular carcinoma
Bile duct cancer, extrahepatic
Capecitabine
Esophageal disorder
Breast Neoplasms
Stomach cancer
Camptothecin
Recurrence
Carcinoma
Gall bladder cancer

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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