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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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)


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Michele Basche

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02467

NCT ID:

NCT00039390

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location
University of Colorado Denver, Colorado  80217