Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

NCT00227734 | Completed Phase 2 DMC

• 2 other identifiers: SAKK 41/04EU-20525
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 18

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. 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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine and oxaliplatin together with cetuximab is more effective than capecitabine and oxaliplatin in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment

Secondary Outcomes (5)

• Clinical benefit (CR, PR, and stable disease [SD]) measured at 18 weeks after randomization

• Time to progression

• Overall survival

• Time to treatment failure measured after completion of study treatment

• Adverse drug reactions measured after completion of study treatment

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.

Drug: capecitabine and oxaliplatin

Arm II

ACTIVE COMPARATOR

Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8

Drug: capecitabine and oxaliplatin + cetuximab

Interventions

capecitabine and oxaliplatin + cetuximab DRUG

cetuximab

Arm II

capecitabine and oxaliplatin DRUG

capecitabine and oxaliplatin without cetuximab

Arm I

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic colorectal cancer * Unresectable disease * Primary tumor or metastases must be epidermal growth factor receptor-positive by immunohistochemistry * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by CT scan * Measurable lesion must not be in a previously irradiated area * No prior or current CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal Renal * Creatinine clearance \> 50 ml/min Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past 12 months * No other significant cardiac disease Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 12 months after study participation * Negative pregnancy test * No peripheral neuropathy of any origin \> grade 1 (e.g., alcohol or diabetes) * No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication * No severe reaction attributed to fluoropyrimidine therapy * No known hypersensitivity to fluorouracil or any other component of the trial drugs * No known dihydropyrimidine dehydrogenase deficiency * No other medical condition (e.g., uncontrolled diabetes or active autoimmune disease), geographical situation, or psychiatric disorder that would preclude study compliance * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for advanced or metastatic cancer * At least 6 months since prior adjuvant chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 30 days since prior experimental drugs * No other concurrent experimental drugs * No concurrent drugs that are contraindicated for use with the trial drugs * No other concurrent anticancer therapy * No concurrent sorivudine or any of its chemically-related analogues (e.g., lamivudine)

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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (18)

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Hirslanden Klinik Aarau

Aarau, CH-5001, Switzerland

Location

Praxis Dr. Streit

Baden, 5404, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Spitaeler Chur AG

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Kantonsspital

Liestal, CH-4410, Switzerland

Location

Ospedale Civico

Lugano, CH-6900, Switzerland

Location

Praxis Dr. Beretta

Rheinfelden, 4310, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Stadtspital Waid

Zurich, CH-8037, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• Borner M, Koeberle D, Von Moos R, Saletti P, Rauch D, Hess V, Trojan A, Helbling D, Pestalozzi B, Caspar C, Ruhstaller T, Roth A, Kappeler A, Dietrich D, Lanz D, Mingrone W; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. Ann Oncol. 2008 Jul;19(7):1288-1292. doi: 10.1093/annonc/mdn058. Epub 2008 Mar 17.

  PMID: 18349029 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Cetuximab

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; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Markus M. Borner, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

• Dieter Koeberle, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: June 1, 2004
• Primary Completion: October 1, 2005
• Study Completion: February 1, 2006
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CH (18)