Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 75	Other	FRE-GERCOR-GEM-GEMOX/D00-3 EU-20324, NCT00075452

Objectives

Primary

1. Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.

Secondary

1. Compare the time of response in patients treated with these regimens.
2. Compare the clinical benefit of and tolerance to these regimens in these patients.
3. Compare the quality of life of patients treated with these regimens.
4. Compare the progression-free survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed pancreatic adenocarcinoma
  • Locally advanced or metastatic disease
  • Unresectable disease



• Measurable disease
  • At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner



• No adenocarcinoma of the bile ducts or ampulla of Vater



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No concurrent corticosteroids except for antiemetic therapy

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Patient Characteristics:

Age

• 18 to 75

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

Hepatic

• Bilirubin less than 1.5 times normal
• Alkaline phosphatase less than 5 times normal

Renal

• Creatinine less than 1.5 times normal
• No uncontrolled or persistent hypercalcemia

Cardiovascular

• No serious cardiac failure

Pulmonary

• No serious respiratory failure

Other

• Pain must be stabilized or controlled before initiation of study treatment
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other untreatable malignant tumor
• No serious psychological, familial, social, or geographical condition that would preclude study participation
• No neuropathy that would preclude study participation

Expected Enrollment

A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Outcomes

Overall survival

Time to response
Clinical benefit
Quality of life
Progression-free survival

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

Quality of life is assessed at baseline and then every 2 months.

Louvet C, Labianca R, Hammel P, et al.: Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol 23 (15): 3509-16, 2005.[PUBMED Abstract]

Huguet F, André T, Hammel P, et al.: Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol 25 (3): 326-31, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Christophe Louvet, MD, PhD, Study coordinator		Ph: 33-1-49-282-343 Email: christophe.louvet@sat.aphp.fr

Registry Information
Official Title		Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
Trial Start Date		2003-11-18
Registered in ClinicalTrials.gov		NCT00075452
Date Submitted to PDQ		2003-11-17
Information Last Verified		2007-05-17

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