Clinical trial NCT00303745: Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Official title: Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-03-17
Enrollment: 78
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Objective response
measure: Stable disease rate
Secondary outcomes:
measure: Tolerability
measure: Quality of life
measure: Progression-free and overall survival
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Centre Hospitalier d'Abbeville
city: Boucher
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Boulogne
country: France
facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne
city: Chalon Sur Saone
country: France
facility: Centre Hospitalier
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Dijon
country: France
facility: Hopital Du Bocage
city: Guilherand Granges
country: France
facility: Clinique Pasteur
city: Le Havre
country: France
facility: CMC Les Ormeaux
city: Le Mans
country: France
facility: C. H. Du Mans
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Lormont
country: France
facility: Polyclinique des Quatre Pavillons
city: Orleans
country: France
facility: CHR D'Orleans - Hopital de la Source
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Cochin
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan
city: Reims
country: France
facility: Hopital Sebastopol, C.H.U. de Reims
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Senlis
country: France
facility: C.H. Senlis
city: Tours
country: France
facility: CHRU de Tours - Hopital Trousseau
city: Verdun
country: France
facility: Centre Hospitalier General - St. Nicolas
Study officials:
affiliation: Hopital Ambroise Pare
name: Emmanuel Mitry, MD, PhD
affiliation: Hopital Bichat - Claude Bernard
name: Thomas Aparicio
role: STUDY_CHAIR
References: