Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

NCT ID: NCT00275119

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30

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.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

fluorouracil

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Principal Investigators

Laurence Moureau-Zabotto, MD

Role: STUDY_CHAIR

Institut Paoli-Calmettes

Locations

Institut Sainte Catherine

Avignon, , France

Hopital Saint Andre

Bordeaux, , France

Clinique Tivoli

Bordeaux, , France

Hopital Drevon

Dijon, , France

CHU de Grenoble - Hopital de la Tronche

Grenoble, , France

Hopital Saint - Louis

La Rochelle, , France

Clinique Victor Hugo

Le Mans, , France

Clinique Saint Jean

Lyon, , France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, , France

Hopital Saint Antoine

Paris, , France

Hopital Tenon

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 18309942 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

GERCOR-D03-1

Identifier Type: -

Identifier Source: secondary_id

EU-20570

Identifier Type: -

Identifier Source: secondary_id

SANOFI-GERCOR-D03-1

Identifier Type: -

Identifier Source: secondary_id

CDR0000454568

Identifier Type: -

Identifier Source: org_study_id