Expired Study
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Denver, Colorado 80217


Purpose:

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


Study summary:

OBJECTIVES: I. Determine the maximum tolerated dose of gefitinib and capecitabine in patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. 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.


Criteria:

Inclusion Criteria: - 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) - Performance status - ECOG 0-2 - At least 12 weeks - 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 - 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) - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min - 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 - No concurrent immunotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No concurrent hormonal therapy - At least 28 days since prior radiotherapy - No concurrent radiotherapy - 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)


Study is Available At:


Original ID:

NCI-2012-02467


NCT ID:

NCT00039390


Secondary ID:

UCHSC-01479


Study Acronym:


Brief Title:

Gefitinib and Capecitabine in Treating Patients With Advanced Solid Tumors


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)


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

41


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michele Basche
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:April 2002
Primary Completion Date:May 2007
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 24, 2013
First Received Date:June 6, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Maximum-tolerated dose (MTD) defined as the those below that results in dose-limiting toxicity (DLT) in >= 2 of 6 new patients, as assessed by CTCAE version 3.0
Time Frame:28 days
Safety Issues:True
Outcome Type:Primary Outcome
Measure:DTL defined as any grade 3 or greater non-hematological toxicity, and grade 3 or greater skin rash, grade 4 thrombocytopenia and/or neutropenia as assessed by CTCAE version 3.0
Time Frame:28 days
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Pharmacological profile
Time Frame:At baseline, at 30 minutes, at 1, 2, 3, and 4 hours of days 8, 14, and 21 (course 1)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:capecitabine
Description:Given orally (PO)
Arm Name:Treatment (capecitabine, gefitinib)
Other Name:CAPE
Intervention Type:Drug
Name:gefitinib
Description:Given PO
Arm Name:Treatment (capecitabine, gefitinib)
Other Name:Iressa
Intervention Type:Other
Name:pharmacological study
Description:Correlative studies
Arm Name:Treatment (capecitabine, gefitinib)
Other Name:pharmacological studies
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (capecitabine, gefitinib)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (capecitabine, gefitinib)
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Lam ET, O'Bryant CL, Basche M, Gustafson DL, Serkova N, Baron A, Holden SN, Dancey J, Eckhardt SG, Gore L. A phase I study of gefitinib, capecitabine, and celecoxib in patients with advanced solid tumors. Mol Cancer Ther. 2008 Dec;7(12):3685-94.
PMID:19074845

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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