Clinical trial NCT00268333: Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon
adenocarcinoma of the rectum
stage IV colon cancer
stage III colon cancer
stage III rectal cancer
stage IV rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-12-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: Overall survival
measure: Disease-free survival
measure: Primary site of recurrence
measure: Time to recurrence
measure: Quality of life
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
city: Dijon
country: France
facility: Hopital Drevon
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Lormont
country: France
facility: Polyclinique des Quatre Pavillons
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Tenon
city: Reims
country: France
facility: Polyclinique De Courlancy
city: Senlis
country: France
facility: C.H. Senlis
Study officials:
affiliation: Institut Sainte Catherine
name: Laurent Mineur, MD
role: STUDY_CHAIR
References: