Know Cancer

forgot password

Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.

Phase 3
18 Years
80 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.


- Compare the efficacy of intermittent high-dose oxaliplatin in combination with a
simplified bimonthly regimen of leucovorin calcium (LV) and fluorouracil (5-FU) vs
standard dose oxaliplatin in combination with the standard bimonthly regimen of LV and
5-FU in patients with metastatic colorectal cancer.

- Determine the time to treatment failure, tolerance, response rate, and overall survival
in patients treated with these 2 regimens.

- Compare quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to treatment center, performance status (0-1 vs 2), and number of metastatic sites
(1 vs more than 1). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1, and leucovorin calcium IV
over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2.

- Arm II: Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours followed
by 5-FU IV over 46 hours beginning on day 1 for courses 1-6 and 19-24. For courses
7-18, patients receive leucovorin calcium IV followed by 5-FU IV as above beginning on
day 1.

Courses repeat every 14 days in both arms in the absence of disease progression or
unacceptable toxicity.

Quality of life is assessed at baseline, after courses 4 and 6, and every 6 courses

Patients are followed monthly for 3 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 460 patients (230 per treatment arm) will be accrued for this
study within 18 months.

Inclusion Criteria


- Histologically confirmed unresectable metastatic adenocarcinoma of the colon or

- Bidimensionally measurable or evaluable disease outside previously irradiated area

- No bone metastasis as target lesion

- At least 1 cm if spiral CT scan OR

- At least 2 cm if conventional CT scan

- No CNS metastasis

- No symptomatic ascites or pleural effusion that is not evacuated

- No total or partial bowel obstruction



- 18 to 80

Performance status:

- ECOG 0-2

- WHO 0-2

Life expectancy:

- Not specified


- Neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Alkaline phosphatase less than 5 times upper limit of normal (ULN)


- Creatinine less than 3 times ULN

- No uncontrolled hypercalcemia


- No uncontrolled congestive heart failure, angina pectoris, hypertension, or


- No peripheral sensory neuropathy

- No prior significant neurologic or psychiatric disorders

- No other malignancy within past 5 years except adequately treated carcinoma in situ
of the cervix or basal or squamous cell skin carcinoma

- No active infection

- No other concurrent serious disease

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- No prior immunotherapy for metastatic disease


- Prior adjuvant chemotherapy allowed, provided progression-free interval of more than
6 months since end of last course

- No prior oxaliplatin or irinotecan

- No prior chemotherapy for metastatic disease

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No concurrent radiotherapy


- Concurrent surgery allowed


- At least 30 days since other prior investigational drugs

- No other concurrent investigational treatment

- No other concurrent antitumoral treatment

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Aimery de Gramont, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Saint Antoine


United States: Federal Government

Study ID:




Start Date:

January 2000

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