Clinical trial NCT00016978: Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Previously Treated With Irinotecan
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil and leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with irinotecan. 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Scottsdale Oncology Program
state: Arizona
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Cedar Rapids
country: United States
facility: Oncology Associates of Cedar Rapids
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Clinic
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Bismarck
country: United States
facility: Medcenter One Health System
state: North Dakota
city: Fargo
country: United States
facility: CCOP - Merit Care Hospital
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Health Systems
state: North Dakota
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital Oncology Program
state: Ohio
city: Tulsa
country: United States
facility: CCOP - Sooner State
state: Oklahoma
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Mayo Clinic
name: Henry C. Pitot, MD
role: STUDY_CHAIR
References: