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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303745
First received: March 15, 2006
Last updated: July 23, 2008
Last verified: December 2006
  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 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00303745     History of Changes
Other Study ID Numbers: CDR0000453857, FFCD-0305, EU-20545, EUDRACT-2004-004742-40
Study First Received: March 15, 2006
Last Updated: July 23, 2008
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Camptothecin
Capecitabine
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014