Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery - Full Text View

Sponsored by:	Federation Francophone de Cancerologie Digestive
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303745

Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine Drug: irinotecan hydrochloride	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer

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

Primary Outcome Measures:

Objective response [ Designated as safety issue: No ]
Stable disease rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability [ Designated as safety issue: Yes ]
Quality of life [ Designated as safety issue: No ]
Progression-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	78
Study Start Date:	June 2006

Detailed Description:

OBJECTIVES:

Primary

Compare the objective response or stable disease rate in elderly patients with unresectable, progressive, metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine.

Secondary

Compare the tolerability of these regimens in these patients.
Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens.
Compare the progression-free and overall survival of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), number of associated comorbidities (Charlson index 0-2 vs > 2), and age (75-79 vs ≥ 80). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 12 weeks thereafter.

After completion of study therapy, patients are followed every 12 weeks.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	75 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- Unresectable disease
- Documented progressive disease during first-line/palliative chemotherapy
Measurable disease ≥ 1 cm that is outside prior radiation field
No brain metastases

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Life expectancy ≥ 3 months
No contraindication to chemotherapy
Creatinine clearance ≥ 40 mL/min
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement)
Bilirubin ≤ 1.5 times normal
Transaminases ≤ 5 times normal
No symptomatic coronary disease or cardiac insufficiency
No enteropathy or chronic diarrhea
No unresolved intestinal occlusion or subocclusion
No history of severe unexpected reaction to a fluoropyrimidine
No other active malignancy in the past 2 years
No hypersensitivity to irinotecan hydrochloride or its excipients
No hypersensitivity to capecitabine or fluorouracil

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior extensive resection
No concurrent sorivudine or similar analogs (e.g., brivudine)
No other concurrent anticancer therapy
Concurrent radiotherapy allowed for nontarget lesions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303745

Locations

France
C. H. Du Mans
Le Mans, France, 72037
C.H. Senlis
Senlis, France, 60309
Centre Eugene Marquis
Rennes, France, 35042
Centre Hospitalier d'Abbeville
Abbeville, France, 80101
Centre Hospitalier de Perpignan
Perpignan, France, 66046
Centre Hospitalier General - St. Nicolas
Verdun, France, 55107
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne, France, F-92104
Centre Hospitalier
Chalon Sur Saone, France, F-71321
CHR D'Orleans - Hopital de la Source
Orleans, France, 45100
CHRU de Tours - Hopital Trousseau
Tours, France, 37044
CHU Pitie-Salpetriere
Paris, France, 75651
Polyclinique des Quatre Pavillons
Lormont, France, 33310
CMC Les Ormeaux
Le Havre, France, 76600
Hopital Antoine Beclere
Clamart, France, 92141
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Charles Nicolle
Rouen, France, 76031
Hopital Cochin
Paris, France, 75674
Hopital Du Bocage
Dijon, France, 21034
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Robert Boulin
Libourne, France, 33500
Hopital Sebastopol, C.H.U. de Reims
Reims, France, 51092
Polyclinique Bordeaux Nord Aquitaine
Boucher, France, 33300
Clinique Pasteur
Guilherand Granges, France, 07500

Sponsors and Collaborators

Federation Francophone de Cancerologie Digestive

Investigators

Investigator:	Emmanuel Mitry, MD, PhD	Hopital Ambroise Pare
Study Chair:	Thomas Aparicio	Hopital Bichat - Claude Bernard

More Information

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

Study ID Numbers:	CDR0000453857, FFCD-0305, EU-20545, EUDRACT-2004-004742-40
Study First Received:	March 15, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00303745
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the colon
recurrent colon cancer
stage IV colon cancer

adenocarcinoma of the rectum
recurrent rectal cancer
stage IV rectal cancer

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Camptothecin

Recurrence
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009