Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00303758
First received: March 15, 2006
Last updated: March 3, 2014
Last verified: December 2006

March 15, 2006
March 3, 2014
October 2005
March 2012   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00303758 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: 2012 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 2012 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 2012 ] [ Designated as safety issue: No ]
  • Percentage of patients needing second-line therapy [ Time Frame: 2012 ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

  • Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.

Secondary

  • Compare progression-free survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the percentage of these patients needing second-line therapy.
  • Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.

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

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: gemcitabine hydrochloride
  • Drug: leucovorin calcium
  • Active Comparator: LV5FU2 simplifié + cisplatine puis gemcitabine si progression
    LV5FU2 simplifié + cisplatine puis gemcitabine si progression
    Interventions:
    • Drug: cisplatin
    • Drug: fluorouracil
    • Drug: gemcitabine hydrochloride
    • Drug: leucovorin calcium
  • Experimental: gemcitabine puis LV5FU2 simplifié + cisplatine si progression
    gemcitabine puis LV5FU2 simplifié + cisplatine si progression
    Interventions:
    • Drug: cisplatin
    • Drug: fluorouracil
    • Drug: gemcitabine hydrochloride
    • Drug: leucovorin calcium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
March 2012
March 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla

    • Metastatic disease
    • Unresectable disease
  • Measurable disease, meeting the following criteria:

    • No prior radiotherapy to the only site of measurable disease
    • Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods
  • No brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 2 months
  • No contraindication to chemotherapy
  • Creatinine clearance > 60 mL/min
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Alkaline phosphatase < 5 times normal
  • Bilirubin ≤ 3 mg/dL
  • No coronary insufficiency
  • No symptomatic cardiac disease
  • Good hydration possible
  • No Child-Pugh class B or C cirrhosis
  • No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior palliative or adjuvant chemotherapy
  • At least 4 weeks since prior radiotherapy
  • No radiotherapy during or for 4 weeks after study therapy
  • No other concurrent anticancer therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00303758
CDR0000453841, FFCD-0301, EU-20543
Not Provided
Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
Not Provided
Study Chair: Jean-Francois Seitz, MD CHU de la Timone
Study Chair: Jean-Louis Legoux, MD Hopital Haut Leveque
Study Chair: Pascal Hammel, MD, PhD Hopital Beaujon
Federation Francophone de Cancerologie Digestive
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP