Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
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| ClinicalTrials.gov Identifier: NCT00227734 |
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Recruitment Status :
Completed
First Posted : September 28, 2005
Last Update Posted : June 5, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: capecitabine and oxaliplatin + cetuximab Drug: capecitabine and oxaliplatin | Phase 2 |
OBJECTIVES:
- Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in patients with epidermal growth factor receptor-positive metastatic unresectable colorectal cancer.
- Compare the objective response (complete and partial response) in patients treated with these regimens.
Secondary
- Compare the safety of these regimens in these patients.
- Compare the clinical benefit (complete response, partial response, or stable disease for at least 18 weeks) in patients treated with these regimens.
- Compare overall survival, time to progression, and time to treatment failure in patients treated with these regimens.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to performance status (0 vs 1), type of metastases (synchronous vs metachronous), prior adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8.
In both arms, courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this study within 1.5 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial |
| Study Start Date : | June 2004 |
| Actual Primary Completion Date : | October 2005 |
| Actual Study Completion Date : | February 2006 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I
Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
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Drug: capecitabine and oxaliplatin
capecitabine and oxaliplatin without cetuximab |
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Active Comparator: Arm II
Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
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Drug: capecitabine and oxaliplatin + cetuximab
cetuximab |
- Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed metastatic colorectal cancer
- Unresectable disease
- Primary tumor or metastases must be epidermal growth factor receptor-positive by immunohistochemistry
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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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227734
| Switzerland | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Hirslanden Klinik Aarau | |
| Aarau, Switzerland, CH-5001 | |
| Praxis Dr. Streit | |
| Baden, Switzerland, 5404 | |
| Kantonsspital Baden | |
| Baden, Switzerland, CH-5404 | |
| Saint Claraspital AG | |
| Basel, Switzerland, CH-4016 | |
| Universitaetsspital-Basel | |
| Basel, Switzerland, CH-4031 | |
| Inselspital Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonsspital Bruderholz | |
| Bruderholz, Switzerland, CH-4101 | |
| Spitaeler Chur AG | |
| Chur, Switzerland, CH-7000 | |
| Hopital Cantonal Universitaire de Geneve | |
| Geneva, Switzerland, CH-1211 | |
| Kantonsspital | |
| Liestal, Switzerland, CH-4410 | |
| Ospedale Civico | |
| Lugano, Switzerland, CH-6900 | |
| Praxis Dr. Beretta | |
| Rheinfelden, Switzerland, 4310 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Regionalspital | |
| Thun, Switzerland, 3600 | |
| City Hospital Triemli | |
| Zurich, Switzerland, 8063 | |
| Stadtspital Waid | |
| Zurich, Switzerland, CH-8037 | |
| UniversitaetsSpital Zuerich | |
| Zurich, Switzerland, CH-8091 | |
| Study Chair: | Markus M. Borner, MD | University Hospital Inselspital, Berne | |
| Principal Investigator: | Dieter Koeberle, MD | Cantonal Hospital of St. Gallen |
Publications of Results:
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00227734 History of Changes |
| Other Study ID Numbers: |
SAKK 41/04 EU-20525 |
| First Posted: | September 28, 2005 Key Record Dates |
| Last Update Posted: | June 5, 2012 |
| Last Verified: | June 2012 |
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stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Colonic Diseases Capecitabine Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Rectal Diseases Oxaliplatin Cetuximab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Immunological |