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

Sponsored by:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00275119

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: oxaliplatin Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy Surgery

Drug Information available for: Fluorouracil Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability [ Designated as safety issue: Yes ]
Recurrence-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Response rate [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Clinical benefits [ Designated as safety issue: No ]
Locoregional and metastatic progression-free survival [ Designated as safety issue: No ]

Study Start Date:

November 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275119

Locations

France
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, F-38043
Clinique Saint Jean
Lyon, France, 69008
Clinique Tivoli
Bordeaux, France, F-33000
Clinique Victor Hugo
Le Mans, France, F-72000
Hopital Drevon
Dijon, France, 21000
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13009
Hopital Saint Andre
Bordeaux, France, 33075
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Institut Sainte Catherine
Avignon, France, 84082
Hopital Saint - Louis
La Rochelle, France, 17000

Sponsors and Collaborators

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Study Chair:

Laurence Moureau-Zabotto, MD

Institut Paoli-Calmettes

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Moureau-Zabotto L, Phélip JM, Afchain P, Mineur L, André 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.

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.

Study ID Numbers:	CDR0000454568, GERCOR-D03-1, EU-20570, SANOFI-GERCOR-D03-1
Study First Received:	January 10, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00275119 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Antiviral Agents
Immunosuppressive Agents
Pancrelipase
Recurrence

Oxaliplatin
Digestive System Diseases
Radiation-Sensitizing Agents
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Fluorouracil
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009