Randomized Phase II Study of FOLFOX Versus FOLFIRI.3 in Gemcitabine-refractory Pancreatic Cancer

NCT00786006 | Completed Phase 2

• 1 other identifier: AMC_P_01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are to evaluate the efficacy and safety of FOLFOX or FOLFIRI.3 combination chemotherapy as second-line salvage chemotherapy in patients with advanced pancreatic carcinoma.

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic cancer; gemcitabine; oxaliplatin; irinotecan; fluorouracil; Failure to gemcitabine chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Every 6 weeks

Secondary Outcomes (3)

• Response rate

  Every 6 weeks

• Overall survival

  every 6 weeks during treatment and every 2 months after off-treatment

• Safety

  Every 2 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

FOLFIRI.3

Drug: FOLFIRI.3

Arm 2

ACTIVE COMPARATOR

FOLFOX

Drug: FOLFOX

Interventions

FOLFIRI.3 DRUG

FOLFIRI.3: Irinotecan 70 mg/m2 (over 60 min) on D1, LV 400 mg/m2 (over 2h) D1, 5-FU 2000 mg/m2 (over 46 hours) from D1, then irinotecan 70 mg/m2(over 60 min) at the end of the 5-FU infusion

Arm 1

FOLFOX DRUG

FOLFOX: oxaliplatin 85 mg/m2 (over 120 min) on D1, LV 400 mg/m2 (over 2hour) on D1, 5-FU 400 mg/m2 IVP on D1, 5-FU 2,000 mg/m2 (over 46 hours)

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven pancreatic adenocarcinoma
• Age 18 year or older
• ECOG performance status of 2 or lower
• Documented disease progression while receiving or within 6 months after discontinuing gemcitabine-based first-line or adjuvant chemotherapy
• Adequate bone marrow function A. WBCs \> 4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL B. Hemoglobin \>9.0 g/dL C. Platelets \> 100,000/µL
• Adequate kidney function (creatinine\<1.5 mg/dL)
• Adequate liver function (bilirubin\<1.5 mg/dL \[\< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction\], transaminases levels\<3 times the upper normal limit, and serum albumin of \>2.5 mg/dL)
• No serious other medical condition that would preclude treatment

You may not qualify if:

• Other tumor type than adenocarcinoma
• Evidence of GI bleeding or GI obstruction
• Presence or history of CNS metastasis
• Axial skeletal radiotherapy within 6 months
• Neuropathy grade 2 or worse

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Yoo C, Hwang JY, Kim JE, Kim TW, Lee JS, Park DH, Lee SS, Seo DW, Lee SK, Kim MH, Han DJ, Kim SC, Lee JL. A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer. Br J Cancer. 2009 Nov 17;101(10):1658-63. doi: 10.1038/sj.bjc.6605374. Epub 2009 Oct 13.

  PMID: 19826418 RESULT

Related Links

• Yoo C et al. British Journal of Cancer 2009;101:1658-1663

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jae-Lyun Lee, MD, PhD

  Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

KR (1)