Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Gefitinib and Capecitabine in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI UCHSC-01479 NCI-3858, NCT00039390, 3858

Objectives

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

Entry 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)

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)

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

University of Colorado Cancer Center at UC Health Sciences Center

Michele Basche, MD, Protocol chair		Ph: 720-848-0300; 800-473-2288

Registry Information
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)
Trial Start Date		2002-07-18
Registered in ClinicalTrials.gov		NCT00039390
Date Submitted to PDQ		2002-04-22
Information Last Verified		2005-05-25
NCI Grant/Contract Number		CA46934

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