Expired Study
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Buffalo, New York 14263


RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel, capecitabine, and cisplatin in treating patients with metastatic or unresectable solid tumors.

Study summary:

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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors

Official Title:

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

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:


Quick Facts

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

Study Source:

Roswell Park Cancer Institute

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Intervention Model: Single Group Assignment, Maski

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Marwan Fakih, MD
Principal Investigator
Roswell Park Cancer Institute

Study Dates

Start Date:May 2002
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:November 2009
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 10, 2014
First Received Date:June 10, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Determine the non-dose-limiting toxic effects associated with this regimen in these patients
Time Frame:Every 21 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors.
Time Frame:Every 21 days
Safety Issues:True

Study Interventions

Intervention Type:Drug
Intervention Type:Drug
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Roswell Park Cancer Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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