search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
capecitabine and oxaliplatin + cetuximab
capecitabine and oxaliplatin
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kantonspital Aarau
  • Hirslanden Klinik Aarau
  • Praxis Dr. Streit
  • Kantonsspital Baden
  • Saint Claraspital AG
  • Universitaetsspital-Basel
  • Inselspital Bern
  • Kantonsspital Bruderholz
  • Spitaeler Chur AG
  • Hopital Cantonal Universitaire de Geneve
  • Kantonsspital
  • Ospedale Civico
  • Praxis Dr. Beretta
  • Kantonsspital - St. Gallen
  • Regionalspital
  • City Hospital Triemli
  • Stadtspital Waid
  • UniversitaetsSpital Zuerich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2005
Last Updated
June 4, 2012
Sponsor
Swiss Group for Clinical Cancer Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00227734
Brief Title
Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
Intervention Type
Drug
Intervention Name(s)
capecitabine and oxaliplatin + cetuximab
Intervention Description
cetuximab
Intervention Type
Drug
Intervention Name(s)
capecitabine and oxaliplatin
Intervention Description
capecitabine and oxaliplatin without cetuximab
Primary Outcome Measure Information:
Title
Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment
Secondary Outcome Measure Information:
Title
Clinical benefit (CR, PR, and stable disease [SD]) measured at 18 weeks after randomization
Title
Time to progression
Title
Overall survival
Title
Time to treatment failure measured after completion of study treatment
Title
Adverse drug reactions measured after completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus M. Borner, MD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dieter Koeberle, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Hirslanden Klinik Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Praxis Dr. Streit
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
CH-5404
Country
Switzerland
Facility Name
Saint Claraspital AG
City
Basel
ZIP/Postal Code
CH-4016
Country
Switzerland
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital Bruderholz
City
Bruderholz
ZIP/Postal Code
CH-4101
Country
Switzerland
Facility Name
Spitaeler Chur AG
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Kantonsspital
City
Liestal
ZIP/Postal Code
CH-4410
Country
Switzerland
Facility Name
Ospedale Civico
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Praxis Dr. Beretta
City
Rheinfelden
ZIP/Postal Code
4310
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Regionalspital
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Stadtspital Waid
City
Zurich
ZIP/Postal Code
CH-8037
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18349029
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs