Sequential Versus Combination Chemotherapy in Advanced Colorectal Carcinoma
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ClinicalTrials.gov Identifier: NCT00312000 |
Recruitment Status :
Completed
First Posted : April 7, 2006
Last Update Posted : September 8, 2008
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Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC).
Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.
Test products:
Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1 (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line: oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity.
Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any other moment when progression is suspected. After cessation of chemotherapy, patients will be followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria.
Condition or disease | Intervention/treatment | Phase |
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Advanced Colorectal Cancer | Drug: capecitabine-irinotecan Drug: capecitabine+irinotecan (1st line) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 820 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | December 2006 |
Arm | Intervention/treatment |
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Active Comparator: 1Capecitabine-irinotecan
1st line- 2nd line (3rd line oxaliplatin plus capecitabine)
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Drug: capecitabine-irinotecan
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Experimental: 2capecitabine plus irinotecan
1st line (2nd line oxaliplatin plus capecitabine)
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Drug: capecitabine+irinotecan (1st line)
q 3 w irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 2 hours after discontinuation of the infusion followed by capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 |
- Overall survival [ Time Frame: study duration ]
- Tumour response [ Time Frame: study duration ]
- Progression free survival [ Time Frame: study duration ]
- Quality of life [ Time Frame: study duration ]
- Toxicity profile [ Time Frame: study duration ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Histology and staging disease
- Histologically proven CRC; advanced disease, not amenable to curative surgery;
- Of Note: In case of a single metastasis, histological or cytological proof of colorectal carcinoma should be obtained prior to randomisation.
- Measurable or evaluable disease; Serum CEA as the only parameter for disease activity is not allowed.
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General conditions
- Written informed consent;
- Age 18 years and above;
- WHO performance status 0-2;
- Adequate bone marrow function(WBC > 3.0 x 109/L, platelets > 100 x 109/L, Hb > 6 mmol/L);
- Adequate hepatic function: total bilirubin < 1. 5 x upper normal limit, ASAT and ALAT < 3 x upper normal limits; in case of liver metastases < 5 x upper normal limits
- Adequate renal function: creatinin < 1. 5 x upper normal limits.
- Other - Expected adequacy of follow-up.
Exclusion Criteria:
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General conditions
- Pregnancy or lactation;
- Patients (M/F) with reproductive potential not implementing adequate contraceptives measures.
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Prior or current history
- Prior chemotherapy for advanced disease; prior adjuvant chemotherapy is allowed provided that the last administration was given > 6 months prior to randomisation.
- Serious concomitant diseases preventing the safe administration of chemotherapy or likely to interfere with the study assessments;
- Serious active infections;
- Inflammatory bowel disease or other diseases associated with chronic diarrhoea;
- Previous extensive irradiation of the pelvis or abdomen;
- Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin.
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Concomitant treatments
- Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
- Concurrent treatment with any other anti-cancer therapy.
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): NCT00312000
Principal Investigator: | C. J. A. Punt, Prof.Dr. | University Medical Center St. Radboud, Nijmegen, The Netherlands |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | C.J.A. Punt, MD PhD, DCCG |
ClinicalTrials.gov Identifier: | NCT00312000 |
Other Study ID Numbers: |
CAIRO1 |
First Posted: | April 7, 2006 Key Record Dates |
Last Update Posted: | September 8, 2008 |
Last Verified: | September 2008 |
colorectal cancer capecitabine irinotecan oxaliplatin |
Colorectal Neoplasms Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Capecitabine Irinotecan Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |