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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

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


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.

PROJECTED ACCRUAL: A maximum of 44 patients will be accrued for this study over
approximately 2-3 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066991

NCT ID:

NCT00003834

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • liver metastases
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Colonic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Medcenter One Health SystemBismarck, North Dakota  58501