Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT00112658
• Recruitment Status: Completed
• First Posted: June 3, 2005
• Last Update Posted: March 8, 2021
• Sponsor: UNICANCER
• Information provided by (Responsible Party): UNICANCER

Tracking Information

• First Submitted Date: June 2, 2005
• First Posted Date: June 3, 2005
• Last Update Posted Date: March 8, 2021
• Actual Study Start Date: November 2004
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2007)

• Objective response rate (Phase II)
• Survival (Phase III)

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: April 9, 2007)

• Toxicity
• Progression-free survival (Phase III)
• Quality of life (Phase III)
• Overall response rate (Phase III)

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
• Official Title: Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

Brief Summary

RATIONALE: Drugs used in chemotherapy 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) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

Detailed Description

OBJECTIVES:

Primary

• Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II)
• Compare the survival of patients treated with these regimens. (Phase III)

Secondary

• Compare the toxicity of these regimens in these patients.
• Compare progression-free survival of patients treated with these regimens. (Phase III)
• Compare the overall response rate in patients treated with these regimens. (Phase III)
• Compare quality of life of patients treated with these regimens. (Phase III)

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days.
• Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
• Condition: Pancreatic Cancer

Intervention

• Drug: fluorouracil
• Drug: gemcitabine hydrochloride
• Drug: irinotecan hydrochloride
• Drug: leucovorin calcium
• Drug: oxaliplatin

Study Arms

• Experimental: Folfirinox
  Interventions:

  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
  • Drug: oxaliplatin
• Active Comparator: Gemcitabine
  Intervention: Drug: gemcitabine hydrochloride

Publications *

• Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
• Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.
• Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 15, 2021): 342
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 30, 2010
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • No other pancreatic tumor type, including either of the following:

    • Neuroendocrine tumor
    • Acinar cell tumor
  • Metastatic disease
• Measurable disease in an area not previously irradiated
• No cerebral metastases or meningeal involvement of the tumor

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)

Renal

• Creatinine < 120 mmol/L

Cardiovascular

• No prior myocardial infarction
• No prior angina
• No uncompensated cardiac or coronary insufficiency
• No symptomatic arrhythmia

Gastrointestinal

• No prior inflammatory bowel disease
• No prior chronic diarrhea
• No unresolved symptomatic occlusion or subocclusion of the bowel

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No ongoing active infection
• No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No contraindication to study treatment
• No other serious medical disorder that would preclude study treatment
• No psychiatric disorder or social or geographic situation that would preclude study participation
• Not detained or under the guardianship of another person

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• No concurrent participation in another clinical trial using therapeutic experimental agents

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00112658
• Other Study ID Numbers: CDR0000430100; FRE-FNCLCC-ACCORD-11/0402; EU-20512
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: UNICANCER
• Original Responsible Party: Not Provided
• Current Study Sponsor: UNICANCER
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Thierry Conroy, MD; Centre Alexis Vautrin

• PRS Account: UNICANCER
• Verification Date: March 2021