Combination Chemotherapy in Treating Patients With Colorectal Cancer

NCT00039208 | Completed Phase 2

• 1 other identifier: EORTC-05011
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 20

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy

Secondary Outcomes (6)

• Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy, excluding those who stopped prior to course 3 for reasons other than toxicity

• Peak delivery time for CPT11 activity over the first 3 courses

• Peak delivery time for CPT11 tolerability and efficacy over the first 6 courses

• Severe toxic events assessed by CTC v2.0 after each course of chemotherapy

• Progression-free survival

Interventions

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Unresectable metastatic or locoregional disease * At least 1 measurable lesion outside a previously irradiated area or an area treated with physical devices (e.g., cryotherapy, laser, or thermoablation) * No prior enrollment in EORTC-05963 * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count greater than 2,000/mm\^3 * Platelet count at least 90,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 times ULN * No uncontrolled hypercalcemia Cardiovascular: * No overt cardiac disease Pulmonary: * No severe respiratory illness Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Male patients must use effective barrier contraception during and for up to 6 months after study * No baseline diarrhea greater than grade I (must have less than 4 stools per 24 hours) * No prior grade III or IV toxicity related to irinotecan * No sensory or motor neuropathy with functional impairment * No prior hypersensitivity to any study drug * No other primary tumor except basal cell skin cancer or carcinoma in situ of the cervix * No uncontrolled infectious or chronic disease * No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent prophylactic growth factor therapy Chemotherapy: * At least 1 month since prior chemotherapy * No prior irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as combination therapy * Other prior therapy containing irinotecan and/or oxaliplatin allowed * No more than 1 prior chemotherapy regimen for metastatic or locoregional disease * Adjuvant chemotherapy considered first-line therapy if tumor relapsed within 6 months of completion of therapy Endocrine therapy: * No concurrent corticosteroids except for emergencies Radiotherapy: * See Disease Characteristics * Palliative radiotherapy for bone lesion allowed except for disease progression Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (20)

Centre Hospitalier Notre Dame - Reine Fabiola

Charleroi, 6000, Belgium

Location

Clinique Saint-Joseph

Liège, B 4000, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Clinique Sainte Elisabeth

Namur, 5000, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Azienda Sanitaria di Bolzano

Bolzano, 39100, Italy

Location

Universita G.D'Annunzio Di Chieti

Chieti, 66100, Italy

Location

Ospedale San Carlo Borromeo

Milano (Milan), 20153, Italy

Location

Azienda Ospedale S. Luigi at University of Torino

Orbassano, (Torino), 10043, Italy

Location

Fondazione Salvatore Maugeri

Pavia, I-27100, Italy

Location

Ospedale Oncologico Regionale

Rionero in Vulture, I-58028, Italy

Location

Istituto Regina Elena

Rome, 00161, Italy

Location

Istituto Clinico Beato Matteo

Vigevano, 27029, Italy

Location

Hospital Fernando Fonseca

Amadora, P-2700, Portugal

Location

Related Publications (1)

• Garufi C, Focan C, Tumolo S, et al.: Time finding study of chronomodulated irinotecan (I), fluorouracil (F), leucovorin (L) and oxaliplatin (O) (chronoIFLO) against metastatic colorectal cancer: results from randomized EORTC 05011 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-2566, 2007.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Carlo Garufi, MD

  Istituti Fisioterapici Ospitalieri - Roma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2002
• Primary Completion: August 1, 2005
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

PT (1); BE (5); IT (8); FR (6)