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Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003834
Recruitment Status : Completed
First Posted : April 14, 2004
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Drugs used in chemotherapy 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with liver metastases from colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 2

Detailed Description:

OBJECTIVES: I. Evaluate the efficacy of treatment with oxaliplatin, fluorouracil, and leucovorin calcium in terms of the resectability rate in patients with unresectable advanced colorectal carcinoma confined to the liver. II. Assess this regimen in terms of response rate, toxicity, and overall survival in these patients.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum (Per 04/99 Amendment) Old Title: A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum Confined to the Liver
Study Start Date : March 1999
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oxaliplatin + leucovorin + fluorouracil
Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin



Primary Outcome Measures :
  1. response rate [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: History of carcinoma of the colon or rectum in which the primary site has been completely resected Measurable or evaluable unresectable liver metastases with one or more of the following: Involvement of all 3 major hepatic veins, the portal vein bifurcation, or the retrohepatic vena cava Involvement of the main right or the main left portal vein and the main hepatic vein of the opposite lobe Disease requiring more than a right or left trisegmentectomy Six or more metastatic lesions distributed diffusely in both lobes of the liver

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 3 times upper limit of normal (ULN) No chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of myocardial infarction within the past 6 months No congestive heart failure Other: No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ or other tumor associated with less than 10% probability of death from malignant disease within 5 years of diagnosis Adequate oral nutrition including estimated intake of at least 1,500 calories per day No severe anorexia or frequent nausea and/or vomiting Able to withstand a major operative procedure No neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Concurrent filgrastim or epoetin alfa allowed Chemotherapy: At least one year since prior adjuvant systemic fluorouracil with or without levamisole or leucovorin No prior systemic or hepatic artery infusion chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the liver At least one year since radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy Surgery: At least 21 days since abdominal exploration with or without intestinal resection Other: Oral cryotherapy allowed only on day 2 of each course


Information from the National Library of Medicine

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): NCT00003834


Locations
Show Show 21 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Steven R. Alberts, MD Mayo Clinic
Publications of Results:
Alberts SR, Horvath W, Donohue J, et al.: Oxaliplatin (OXAL), 5-Fluorouracil (5FU), and Leucovorin (CF) for patients (Pts) with liver only metastases (Mets) from colorectal cancer (CRC): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-511, 2001.

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003834    
Other Study ID Numbers: NCCTG-974651
CDR0000066991 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 14, 2004    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
liver metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Leucovorin
Fluorouracil
Oxaliplatin
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents