Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268333
• Other study ID #: CDR0000453784
• Secondary ID: GERCOR-C04-1EU-2
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2005
• Last updated: February 6, 2009
• Start date: August 2005

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• fluorouracil

• leucovorin calcium

• oxaliplatin

Procedure:
• neoadjuvant therapy

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
France	Hopital Drevon	Dijon
France	Hopital Robert Boulin	Libourne
France	Polyclinique des Quatre Pavillons	Lormont
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Tenon	Paris
France	Polyclinique De Courlancy	Reims
France	C.H. Senlis	Senlis

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	Overall survival			No
Secondary	Disease-free survival			No
Secondary	Primary site of recurrence			No
Secondary	Time to recurrence			No
Secondary	Quality of life			No