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Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Adenocarcinoma, Liver Metastases

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Trial Information

Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma


When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes
be removed surgically. However, the cancer has a chance or reoccurring in the liver or
elsewhere in the body. This study will determine if giving chemotherapy treatment before
the surgery can reduce the chances that the cancer will come back.


Inclusion Criteria:



- stage IV colorectal cancer isolated to the liver

- one measurable lesion

- metastases are completely resectable or amenable to ablation

- Karnofsky >70

- Adequate bone marrow function

- adequate hepatic function

- adequate renal function

- informed consent

Exclusion Criteria:

- primary tumor not controlled by locoregional treatments

- bilateral portal vein and/or hepatic artery involvement

- previous chemotherapy directed at treatment of metastatic colorectal cancer

- underlying acute or chronic liver disease

- Gilbert's disease

- patients receiving phenytoin or phenobarbital prophylaxis

- presence of any concurrent medical or psychiatric condition that serves as a
contraindication to surgery or chemotherapy

- pregnancy

- malignancy other than basal cell or squamous cell carcinoma of the skin within the
preceding 5 years

- use of another investigational medication concurrently or within 4 months of
enrollment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Principal Investigator

Oliver Bathe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

CPTAIV-0020-357

NCT ID:

NCT00168155

Start Date:

January 2002

Completion Date:

May 2009

Related Keywords:

  • Colorectal Adenocarcinoma
  • Liver Metastases
  • resectable liver metastases
  • colorectal adenocarcinoma
  • survival
  • neoadjuvant chemotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms
  • Colorectal Neoplasms

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