Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin
18 Years
80 Years
Both
Colorectal Cancer
Trial Information
Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent metastatic colorectal cancer
treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by
radiotherapy and concurrent fluorouracil and oxaliplatin.
Secondary
- Determine the overall survival and disease-free survival of patients treated with this
regimen.
- Determine the primary site of recurrence and time to recurrence in patients treated
with this regimen.
- Determine quality of life of patients treated with this regimen.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
- Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin
calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously
over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the
absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients
with stable or responding disease proceed to chemoradiotherapy.
- Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5
weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also
undergo radiotherapy 5 days a week for 5 weeks beginning on day 1.
Quality of life is assessed at baseline, 1 week after the completion of neoadjuvant
chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the
completion of study treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease isolated to the following lymph nodes:
- Aortic
- Interaortic
- Celiomesenteric
- Retroperitoneal, including the following sites:
- Peri-uretal
- Liver
- Iliac
- Clavicle
- Mediastinum
- Inguinal
- Cervical
- Incompletely resected disease
- Recurrent disease, defined by 1 of the following criteria:
- Progression occurred within 6 months after prior oxaliplatin or after the
patient received no prior oxaliplatin
- Progressive disease after cisplatin or fluorouracil
- Must be able to be encompassed in radiation field
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Life expectancy more than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000 /mm^3
- Alkaline phosphatase ≤ 5 times normal
- Bilirubin ≤ 2 times normal
- Creatinine < 2 times normal or creatinine clearance ≥ 40 mL/min
- No peripheral neuropathy > grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No weight loss > 15% since diagnosis of recurrent disease
- No uncontrolled heart disease
- No angina
- No symptomatic disease of the inferior artery
- No psychological, familial, sociological, or geographical condition that would
preclude study treatment or compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy
- No concurrent corticosteroids
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Laurent Mineur, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Sainte Catherine
Authority:
United States: Federal Government
Study ID:
CDR0000453784
NCT ID:
NCT00268333
Start Date:
August 2005
Completion Date:
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- stage IV colon cancer
- stage III colon cancer
- stage III rectal cancer
- stage IV rectal cancer
- Colorectal Neoplasms
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