Capecitabine in Treating Older Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049335

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

Drug Information available for: Capecitabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	February 2003
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study.
Determine the anticancer efficacy of capecitabine, in terms of objective response rate (confirmed and unconfirmed, complete and partial responses) and 2-year survival, in these patients.
Determine the toxicity and tolerability of this drug in these patients.
Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug.
Determine the clinical pharmacology of this drug in these patients.
Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature.

OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59).

Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed metastatic or recurrent colorectal cancer not amenable to surgical resection
Measurable disease
No known brain metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

70 and over OR
18 to 59

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

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

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
SGOT or SGPT no greater than 2 times ULN

Renal

Creatinine no greater than 2 times ULN
Creatinine clearance greater than 50 mL/min

Other

Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative
No known seizure disorder
No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for advanced cancer
Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

At least 4 weeks since prior sorivudine or brivudine
No concurrent sorivudine or brivudine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049335

Show 90 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Heinz-Josef Lenz, MD

USC/Norris Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000258049, SWOG-S0030
Study First Received:	November 12, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00049335 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009