Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer

NCT00392470 | Unknown Phase 1

• 5 other identifiers: CDR0000512816CHUV-CEPO-CORCC-204-5EU-20645PFIZER-CHUV-CAPO-CARK-204-5MERCK-CHUV-CAPO-CARK-204-5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectum; stage III rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (2)

• Radiological (clinical) tumor response before surgery

• Pathologic response rate and histological degree of tumor regression as measured by Mandard TRG score

Interventions

cetuximab BIOLOGICAL

irinotecan hydrochloride DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

3-dimensional conformal radiation therapy RADIATION

intensity-modulated radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum * T3-4 and/or N+ (stage IIIB, IIIC, or IV disease) * Liver or lung metastasis allowed * No recurrent disease PATIENT CHARACTERISTICS: * WHO performance status 0 or 1 * Hematologic, liver, and renal function normal * Considered fit for chemotherapy, radiotherapy, and surgery * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No symptomatic heart disease or myocardial infarction during the past 6 months * No chronic inflammatory bowel disease * No malignant tumor during the past 5 years except for completely surgically resected carcinoma of the cervix or squamous cell carcinoma of the skin * No other concurrent malignant tumor PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for rectal cancer * No prior radiotherapy to the pelvis

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (3)

Kantonsspital Aarau

Aarau, CH-5000, Switzerland

RECRUITING

Institut Ludwig de Recherche sur le Cancer

Épalinges, 1066, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; Irinotecan; Neoadjuvant Therapy; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Michael Montemurro, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: August 1, 2006
• Last Updated: May 25, 2011

Record last verified: 2008-04

Locations

CH (3)