A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
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 Institute | Buffalo, New York 14263 |
