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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00275119
First received: January 10, 2006
Last updated: February 6, 2009
Last verified: January 2006
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Institut Sainte Catherine
Avignon, France, 84082
Hopital Saint Andre
Bordeaux, France, 33075
Clinique Tivoli
Bordeaux, France, F-33000
Hopital Drevon
Dijon, France, 21000
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, F-38043
Hopital Saint - Louis
La Rochelle, France, 17000
Clinique Victor Hugo
Le Mans, France, F-72000
Clinique Saint Jean
Lyon, France, 69008
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13009
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Laurence Moureau-Zabotto, MD Institut Paoli-Calmettes
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00275119     History of Changes
Other Study ID Numbers: CDR0000454568, GERCOR-D03-1, EU-20570, SANOFI-GERCOR-D03-1
Study First Received: January 10, 2006
Last Updated: February 6, 2009
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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 16, 2014