Capecitabine Combined With Cisplatin In Treating Patients With Locally Advanced Or Metastatic Solid Tumors

Study Overview

Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of capecitabine combined with cisplatin in treating patients who have locally advanced or metastatic solid tumors .

OBJECTIVES: * Determine the dose-limiting toxicity, maximum tolerated dose, and the recommended phase II dose of capecitabine and cisplatin in patients with locally advanced or metastatic cancer of the upper gastrointestinal tract (GI), head and neck, lung, breast, or carcinoma of unknown primary. * Determine the toxic effects of this regimen in these patients. * Evaluate possible antitumor effectiveness of this regimen in these patients. * Determine the toxic effects of cisplatin and capecitabine at the recommended phase II dose in patients with cancer of the upper GI tract. * Determine the overall survival, time to progression, and duration of response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of capecitabine. Patients receive oral capecitabine twice daily for 5, 10, or 14 days. Patients also receive cisplatin IV on day 1 of each course. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The recommended phase II dose is defined as the dose preceding the MTD, provided no more than 3 of 12 patients experience DLT at that dose. Twenty additional patients with cancer of the upper gastrointestinal tract receive treatment with cisplatin and capecitabine at the recommended phase II dose for at least 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 6 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 20-50 patients will be accrued for this study within 1-3 years.

Cancer

DRUG: capecitabine
DRUG: cisplatin

CDR0000068434
P30CA016087 (U.S. NIH Grant/Contract)
NYU-9955
ROCHE-NYU-9955
NCI-G00-1908

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-02-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-04-04
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-04-05
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2011-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed metastatic or locally advanced inoperable carcinoma of the upper gastrointestinal tract, head and neck, lung, breast, or carcinoma of unknown primary
Previously treated and/or resected primary tumors allowed
Hormone receptor status:

Not specified

18 and over

Not specified

Not specified

ECOG 0-2

At least 12 weeks

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Bilirubin less than 2 mg/dL*
AST less than 3 times upper limit of normal (ULN)*
Alkaline phosphatase no greater than 3 times ULN
NOTE:
Unless related to tumor (e.g., cholangiocarcinoma or hepatic metastases)

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min
BUN no greater than 30 mg/dL
NOTE:
Unless related to tumor (e.g., cholangiocarcinoma or hepatic metastases)

No other medical condition that could interfere with oral medication absorption
No prior or concurrent malignancy except surgically cured carcinoma of the cervix or basal cell or squamous cell carcinoma skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative

Not specified

At least 6 months since prior fluorouracil or cisplatin
At least 3 weeks since other prior chemotherapy

Not specified

At least 3 weeks since prior radiotherapy

See Disease Characteristics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Franco M. Muggia, MD, NYU Langone Health

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Chen TT, Ryan T, Potmesil M, et al.: Cisplatin/capecitabine: tolerance and activity in patients with upper gastrointestinal cancers. [Abstract] American Society of Clinical Oncology 2004 Gastrointestinal Cancers Symposium, 22-24 January 2004, San Francisco, CA. A-53, 2004.

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Resources

PatientS

Caregivers

Clinical Trial Record