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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
Est. completion date
Est. primary completion date
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


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
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