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A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), and Leucovorin (CF) in Patients With Metastatic Colorectal Carcinoma Previously Treated With Irinotecan (CPT-11)


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

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Trial Information

A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), and Leucovorin (CF) in Patients With Metastatic Colorectal Carcinoma Previously Treated With Irinotecan (CPT-11)


OBJECTIVES:

I. Determine the tumor response rate in patients treated with oxaliplatin, fluorouracil, and
leucovorin calcium for metastatic colorectal cancer previously treated with irinotecan.

II. Determine the time to tumor progression, time to treatment failure, and overall survival
of patients treated with this regimen.

III. Determine the toxicity of this regimen in this patient population. IV. Assess the
quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and
fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity. Patients achieving a confirmed complete
response for 2 consecutive courses may discontinue study treatment at the investigators
discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during
treatment, and then after the last course of treatment. Patients are followed every 3 months
for 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not
amenable to radiotherapy with curative intent

- Progressive disease no more than 3 months after completion of a prior weekly
irinotecan, fluorouracil, and leucovorin calcium chemotherapy regimen

- At least 1 measurable lesion At least 20 mm in at least one dimension

- No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: ECOG 0-2

- Life expectancy: At least 12 weeks

- Absolute neutrophil count greater than 2,000/mm3

- Platelet count at least 100,000/mm3

- Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)

- AST no greater than 5 times ULN

- Creatinine no greater than 1.5 times ULN OR creatinine clearance greater than 60
mL/min

- No unstable angina No symptomatic congestive heart failure

- No serious uncontrolled cardiac arrhythmia

- No active or uncontrolled infection

- No evidence of other serious illness

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or noninvasive carcinomas

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No concurrent sargramostim (GM-CSF)

- At least 4 weeks since prior chemotherapy

- No more than 1 prior chemotherapy regimen for advanced colorectal cancer

- Prior adjuvant chemotherapy allowed

- No prior radiotherapy to more than 25% of bone marrow

- At least 4 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Henry C. Pitot, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01859

NCT ID:

NCT00016978

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal 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
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Sooner StateTulsa, Oklahoma  74136
Medcenter One Health SystemBismarck, North Dakota  58501
Oncology Associates of Cedar RapidsCedar Rapids, Iowa  52403