Clinical trial NCT00275119: Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Official title: Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, 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 chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Detailed description: OBJECTIVES:

Primary

* Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.

Secondary

* Determine the tolerability of this regimen, in both the short- and long-term, in these patients.
* Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
* Determine the clinical benefits of this regimen in these patients.
* Determine locoregional and metastatic progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

* Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy.
* Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas

  * Locally advanced, nonresectable disease
  * Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery
* No visceral or peritoneal metastases
* No adenocarcinoma of the bile ducts or the ampulla of Vater

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Stable or controlled pain with analgesics
* Not pregnant or nursing
* Neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times normal OR \< 3 mg/dL
* Creatinine clearance ≥ 40 mL/min
* Bilirubin ≤ 1.5 times normal
* Alkaline phosphatase \< 5 times normal
* No medical condition that would preclude study treatment
* No active infection
* Negative pregnancy test
* No serious cardiac or respiratory disease
* No uncontrolled or persistent hypercalcemia
* No pre-existing neuropathy
* No biliary or gastro-duodenal obstruction
* No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder
* No familial, social, geographical, or psychological condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)
* At least 2 months since prior radiotherapy

Primary outcomes:
measure: Progression-free survival
Secondary outcomes:
measure: Tolerability
measure: Recurrence-free survival
measure: Overall survival
measure: Response rate
measure: Quality of life
measure: Clinical benefits
measure: Locoregional and metastatic progression-free survival
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Dijon
country: France
facility: Hopital Drevon
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital de la Tronche
city: La Rochelle
country: France
facility: Hopital Saint - Louis
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lyon
country: France
facility: Clinique Saint Jean
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
Study officials:
affiliation: Institut Paoli-Calmettes
name: Laurence Moureau-Zabotto, MD
role: STUDY_CHAIR
References:
citation: Moureau-Zabotto L, Phelip JM, Afchain P, Mineur L, Andre T, Vendrely V, Lledo G, Dupuis O, Huguet F, Touboul E, Balosso J, Louvet C. Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: a Groupe Coordinateur Multidisciplinaire en Oncologie phase II study. J Clin Oncol. 2008 Mar 1;26(7):1080-5. doi: 10.1200/JCO.2007.12.8223.
citation: Moureau-Zabotto L, Phélip J, Afchain P, et al.: Concomitant administration of weekly oxaliplatin, 5FU continuous infusion and radiotherapy in locally advanced pancreatic cancer (LAPC): a Gercor phase II study. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1077, S173-4, 2006.