Completed

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

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What is being tested

capecitabine

+ cisplatin
+ docetaxel
Drug
Who is being recruted

Unspecified Adult Solid Tumor, Protocol Specific

From 18 to 120 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2002

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: August 4, 2023
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2002Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors 
Principal SponsorRoswell Park Cancer Institute
Last updated: August 4, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
61 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Unspecified Adult Solid Tumor, Protocol Specific
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Roswell Park Cancer InstituteBuffalo, United StatesSee the location

CompletedOne Study Center