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

Colorectal Cancer Clinical Trial

Official title:

Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00303745
• Other study ID #: CDR0000453857
• Secondary ID: FFCD-0305EU-2054
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 15, 2006
• Last updated: July 23, 2008
• Start date: June 2006

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• capecitabine

• irinotecan hydrochloride

Locations

Country	Name	City	State
France	Centre Hospitalier d'Abbeville	Abbeville
France	Polyclinique Bordeaux Nord Aquitaine	Boucher
France	Centre Hospitalier Universitaire Ambroise Pare - Boulogne	Boulogne
France	Centre Hospitalier	Chalon Sur Saone
France	Hopital Antoine Beclere	Clamart
France	Hopital Du Bocage	Dijon
France	Clinique Pasteur	Guilherand Granges
France	CMC Les Ormeaux	Le Havre
France	C. H. Du Mans	Le Mans
France	Hopital Robert Boulin	Libourne
France	Polyclinique des Quatre Pavillons	Lormont
France	CHR D'Orleans - Hopital de la Source	Orleans
France	CHU Pitie-Salpetriere	Paris
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Cochin	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Centre Hospitalier de Perpignan	Perpignan
France	Hopital Sebastopol, C.H.U. de Reims	Reims
France	Centre Eugene Marquis	Rennes
France	Hopital Charles Nicolle	Rouen
France	C.H. Senlis	Senlis
France	CHRU de Tours - Hopital Trousseau	Tours
France	Centre Hospitalier General - St. Nicolas	Verdun

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response			No
Primary	Stable disease rate			No
Secondary	Tolerability			Yes
Secondary	Quality of life			No
Secondary	Progression-free and overall survival			No