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

NCT00084734 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000365571RPCI-RPC-0209
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

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

  Every 21 days

Secondary Outcomes (1)

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

  Every 21 days

Interventions

capecitabine DRUG

Oral

cisplatin DRUG

IV

docetaxel DRUG

IV

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Interventions

Capecitabine; Cisplatin; Docetaxel

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: May 1, 2002
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

US (1)