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Gefitinib and Capecitabine in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: June 6, 2002   Last Updated: February 24, 2009   History of Changes
Sponsor: University of Colorado at Denver and Health Sciences Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039390
  Purpose

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and capecitabine may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and capecitabine in treating patients with advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: capecitabine
Drug: gefitinib
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial Of ZD1839 With Capecitabine In Patients With Advanced Solid Tumors (Formerly a Phase I Trial of ZD1839 With Capecitabine and Celecoxib)

Resource links provided by NLM:


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

Study Start Date: July 2002
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of gefitinib and capecitabine in patients with advanced solid tumors.
  • Determine the dose-limiting toxic effects of this regimen in these patients.
  • Determine the pharmacologic profile of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gefitinib and capecitabine.

Patients receive oral gefitinib once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gefitinib and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 11-41 patients will be accrued for this study within 2.5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
  • No uncontrolled brain metastases, including symptomatic lesions or lesions requiring treatment (e.g., glucocorticoids and/or anticonvulsants)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal (5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • No active infections
  • No other serious concurrent systemic disorders that would preclude study participation
  • No other malignancy
  • No prior hypersensitivity to sulfonamide-based drugs, nonsteroidal anti-inflammatory drugs, or fluorouracil
  • No documented dihydropyrimidine dehydrogenase deficiency
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 28 days since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior investigational agents
  • No other concurrent experimental medications
  • No concurrent drugs known to induce cytochrome P450 3A4 (e.g., rifampin, phenytoin, carbamazepine, or barbiturates)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039390

Locations
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado at Denver and Health Sciences Center
Investigators
Study Chair: Michele Basche, MD University of Colorado at Denver and Health Sciences Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069379, UCHSC-01479, NCI-3858
Study First Received: June 6, 2002
Last Updated: February 24, 2009
ClinicalTrials.gov Identifier: NCT00039390     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Gefitinib
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009