Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

NCT00254137

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed metastatic colorectal cancer.

- EGF-receptor testing.

- No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).

- No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.

- No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.

- Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).

- Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.

- Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).

- Written informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Concurrent treatment of colorectal cancer (except study medication).


- EGF-receptor testing not possible.


- Known DPD-deficiency (no particular screening necessary). Known
Gilbert-Meulengracht-Syndrome (no particular screening necessary).


- Known or expected contraindication against study medication.


- Participation in other studies during 30 days before study entry.


- Prior myocardial infarction, severe renal insufficiency (creatinine clearance
£30ml/min).


- Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin
or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease
during 5 years).


- Known or suspected cerebral metastasis.


- History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.


- Drug or alcohol abuse. Lack of adequate legal capacity.


- Breast-feeding or pregnant women.


- Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or
derivatives.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
Official Title  ICMJE A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.
Brief Summary A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: capecitabine
  • Drug: irinotecan
  • Drug: oxaliplatin
  • Drug: cetuximab
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 14, 2005)
92
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal cancer.
  • EGF-receptor testing.
  • No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
  • No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
  • No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
  • Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).
  • Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.
  • Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).
  • Written informed consent.

Exclusion Criteria:

  • Concurrent treatment of colorectal cancer (except study medication).
  • EGF-receptor testing not possible.
  • Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
  • Known or expected contraindication against study medication.
  • Participation in other studies during 30 days before study entry.
  • Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min).
  • Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years).
  • Known or suspected cerebral metastasis.
  • History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.
  • Drug or alcohol abuse. Lack of adequate legal capacity.
  • Breast-feeding or pregnant women.
  • Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254137
Other Study ID Numbers  ICMJE CRC-02-2004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ludwig-Maximilians - University of Munich
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Sanofi
  • Pfizer
  • Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator:Volker Heinemann, PhD, MDUniversity of Munich - Klinikum Grosshadern
PRS Account Ludwig-Maximilians - University of Munich
Verification Date September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP