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

NCT00303745 | Unknown Phase 2

• 4 other identifiers: CDR0000453857FFCD-0305EU-20545EUDRACT-2004-004742-40
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer; adenocarcinoma of the rectum; recurrent rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (2)

• Objective response

• Stable disease rate

Secondary Outcomes (3)

• Tolerability

• Quality of life

• Progression-free and overall survival

Interventions

capecitabine DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (23)

Centre Hospitalier d'Abbeville

Abbeville, 80101, France

Location

Polyclinique Bordeaux Nord Aquitaine

Boucher, 33300, France

Location

Centre Hospitalier Universitaire Ambroise Pare - Boulogne

Boulogne, F-92104, France

Location

Centre Hospitalier

Chalon-sur-Saône, F-71321, France

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Clinique Pasteur

Guilherand-Granges, 07500, France

Location

CMC Les Ormeaux

Le Havre, 76600, France

Location

C. H. Du Mans

Le Mans, 72037, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45100, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Cochin

Paris, 75674, France

Location

Centre Hospitalier de Perpignan

Perpignan, 66046, France

Location

Hopital Sebastopol, C.H.U. de Reims

Reims, 51092, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

C.H. Senlis

Senlis, 60309, France

Location

CHRU de Tours - Hopital Trousseau

Tours, 37044, France

Location

Centre Hospitalier General - St. Nicolas

Verdun, 55107, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Study Officials

• Emmanuel Mitry, MD, PhD

  Hopital Ambroise Pare

• Thomas Aparicio

  Hopital Bichat - Claude Bernard

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: June 1, 2006
• Last Updated: July 24, 2008

Record last verified: 2006-12

Locations

FR (23)