OPTIMOX1 in Chinese mCRC Patients

A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer

Previous OPTIMOX1 study investigated the use of oxaliplatin discontinuation and reintroduction in a novel stop-and-go strategy. Previously untreated patients were randomly assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 for another 6 cycles (arm B). Data showed that there was no significant difference in median progression-free survival (PFS) and overall survival (OS) between two arms. Furthermore, this study showed lower Grade 3 neurotoxicity rate in arm B (17.9% vs 13.3%, P = 0.12).In order to investigate the efficacy and feasibility of the novel "Stop and go" strategy in Chinese mCRC patients, Prof. Shu Yongqian in JiangShu Province Hospital plans to conduct a randomized controlled study to compare continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line mCRC patients. To avoid the high oxaliplatin dosage related neurotoxicity, FOLFOX4 regimen is chosen in this study.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Oxaliplatin, LV, 5-FU

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The 1st Affiliated Hospital Of NanJing Medical University
      • Contact: Xiaofeng Chen, MD; Phone Number: 6428 86 25 83718836; Email: xiaofengch198019@126.com
      • Principal Investigator: Yongqian Shu, MD
  • Zhejiang
    • HangZhou, Zhejiang, China, 310016
      • Recruiting
      • Zhejiang University affiliated sir run run shaw hospital
      • Contact: Hongming Pan, MD; Phone Number: 0571-86090073; Email: panhongming@tom.com
      • Principal Investigator: Hongming Pan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with histologically confirmed adenocarcinoma of the colon or rectum
• Unresectable metastases
• At least one bidimensionally measurable lesion of ≥ 1 cm
• No previous chemotherapy for metastatic disease; Completed at least more than 1 year oxaliplatin therapy for adjuvant treatment
• 18-75 years old
• ECOG 0-2
• Life expectancy greater than 3 months
• Hemogram: WBC≥4.0 X109/L, ANC ≥2 X109/L, PLT ≥100 X109/L, Hb ≥90g/L,
• Adequate Renal Function
• Adequate Liver Function
• Signed informed consent before the treatment

Exclusion Criteria:

• Patients with previous oxaliplatin based adjuvant chemotherapy within 1 Year
• Completely or partially bowel obstruction
• Presence of peripheral neuropathy (CTC>grade I)
• Severe mental disorder
• CNS metastasis
• With other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina
• With other malignant disease previously or concurrently
• Receive other anti-tumor treatment
• Pregnant or lactating women, or women of child bearing potential without contraceptive method.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU); The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles.	Drug: Oxaliplatin, LV, 5-FU; Arm B(Intervention arm) will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles. FOLFOX4 regimen: OXA 85mg/m2 , 2 hour infusion, d1 , Leucovorin 200 mg/m2 plus 5-FU 400mg IV bolus, then continuous 22 hour 600 mg/m2 infusion on day 1 and 2 Q2W; Other Names: Eloxatin
Experimental: Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU); The arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles	Drug: Oxaliplatin, LV, 5-FU; Arm B(Intervention arm) will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles. FOLFOX4 regimen: OXA 85mg/m2 , 2 hour infusion, d1 , Leucovorin 200 mg/m2 plus 5-FU 400mg IV bolus, then continuous 22 hour 600 mg/m2 infusion on day 1 and 2 Q2W; Other Names: Eloxatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DDC: Duration of Disease Control	Oct2012

Secondary Outcome Measures

Outcome Measure	Time Frame
OS, RR, PFS, DCR, safety,	Oct 2015

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Publications and helpful links

General Publications

• Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): December 2, 2009
• Last Update Submitted That Met QC Criteria: December 1, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: to investigate the efficacy and feasibility of this novel treatment strategy in Chinese mCRC patients; Primary Endpoint:DDC; Secondary Endpoint:OS, RR,DCR, PFS,safety
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: Oxali04882