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A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors


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

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Trial Information

A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in
patients with advanced solid tumors.

- Determine the dose-limiting toxicity and recommended phase II dose of this regimen in
these patients.

Secondary

- Determine the non-dose-limiting toxic effects associated with this regimen in these
patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine any clinical activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and
8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A minimum of 21 patients will be accrued for this study within 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed solid tumor for which standard curative or
palliative measures do not exist or are no longer effective

- Metastatic or unresectable disease

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

Hepatic

- AST and ALT ≤ 2.0 times upper limit of normal (ULN) AND alkaline phosphatase [AP] <
ULN OR

- AP ≤ 4 times ULN AND AST and ALT < ULN

- Bilirubin normal

Renal

- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to ingest oral medications

- No allergy attributed to study drugs, compounds of similar chemical or biological
composition, drugs formulated in polysorbate 80, or other agents used in this study

- No inner ear auditory toxicity ≥ grade 2

- No peripheral neuropathy ≥ grade 2

- No immunodeficiency

- No active or ongoing infection

- No psychiatric illness or social situation that would preclude study compliance

- No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent growth factors (sargramostim [GM-CSF] or filgrastim [G-CSF])

Chemotherapy

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

Endocrine therapy

- Not specified

Radiotherapy

- More than 4 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- No other concurrent investigational agents unless approved by the principal
investigator and medical monitor

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors.

Outcome Time Frame:

Every 21 days

Safety Issue:

Yes

Principal Investigator

Marwan Fakih, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000365571

NCT ID:

NCT00084734

Start Date:

May 2002

Completion Date:

December 2009

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263