Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Leeds
Collaborator:
Medical Research Council
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00070213
First received: October 3, 2003
Last updated: June 9, 2011
Last verified: June 2011
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Purpose
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: FOLFOX regimen Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Capecitabine
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr [ Designated as safety issue: No ]
- Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Compare health assessment, including quality of life, in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap at baseline and 14 and 24 weeks [ Designated as safety issue: No ]
- Compare toxicity/adverse events in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: Yes ]
- Compare overall failure-free survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: No ]
- Compare overall survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: No ]
- Compare health economics in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: No ]
- Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]
- Compare toxicity/adverse events in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 24 weeks [ Designated as safety issue: Yes ]
- Compare patients acceptability in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]
- Compare PFS in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]
- Compare health economics in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]
| Estimated Enrollment: | 460 |
| Study Start Date: | September 2003 |
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:
- Prior or current histologically confirmed primary adenocarcinoma of the colon or rectum with clinical/radiological evidence of advanced/metastatic disease
- Histologically or cytologically confirmed metastatic adenocarcinoma with clinical/radiological evidence of colorectal primary tumor
- Unidimensionally measurable disease
Unfit and unsuitable for full-dose combination chemotherapy, which would include 1 of the following circumstances:
- Unsuitable or unwilling to be entered into any full-dose chemotherapy protocol
- Ineligible or unsuitable for first-line standard combination as per National Institute of Clinical Excellence guidance
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- AST or ALT no greater than 2.5 times ULN
Renal
- Creatinine clearance greater than 50 mL/min OR
- Glomerular filtration rate greater than 30 mL/min
Cardiovascular
- No uncontrolled angina
- No recent myocardial infarction
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No partial or complete bowel obstruction
- No concurrent severe uncontrolled medical illness that would preclude study treatment
- No psychiatric or neurological condition that would preclude giving informed consent or complying with oral study medication
- No other prior or concurrent malignant disease that would preclude study treatment or assessment of response
- No prior neuropathy greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 4 months since prior adjuvant chemotherapy with fluorouracil with or without leucovorin calcium
- More than 1 month since prior rectal chemoradiotherapy with fluorouracil with or without leucovorin calcium
- No prior systemic palliative chemotherapy for metastatic disease
Endocrine therapy
- Not specified
Radiotherapy
- See Chemotherapy
Surgery
- Not specified
Other
- No concurrent brivudine or sorivudine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070213
Locations
| United Kingdom | |
| Clinical Trials and Research Unit of the University of Leeds | |
| Leeds, England, United Kingdom, LS2 9JT | |
| Cookridge Hospital | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Medical Research Council Clinical Trials Unit | |
| London, England, United Kingdom, NW1 2DA | |
| Velindre Cancer Center at Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
Sponsors and Collaborators
University of Leeds
Medical Research Council
Investigators
| Investigator: | Matthew T. Seymour, MA, MD, FRCP | Cookridge Hospital |
| Investigator: | Gareth Griffiths | Medical Research Council |
More Information
Additional Information:
Publications:
Seymour MT, Maughan TS, Wasan HS, et al.: Capecitabine (Cap) and oxaliplatin (Ox) in elderly and/or frail patients with metastatic colorectal cancer: the FOCUS2 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9030, 500s, 2007.
| ClinicalTrials.gov Identifier: | NCT00070213 History of Changes |
| Other Study ID Numbers: | CDR0000330142, NCRI-FOCUS2, MRC-CR09, EU-20303 |
| Study First Received: | October 3, 2003 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the colon adenocarcinoma of the rectum stage IV rectal cancer |
stage IV colon cancer recurrent rectal cancer recurrent colon cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Capecitabine Oxaliplatin Leucovorin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 19, 2013