OPTIMOX1 in Chinese mCRC Patients

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01023633
• Other study ID #: Oxali04882
• Status: Recruiting
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: December 1, 2009
• Start date: October 2009
• Est. completion date: July 2015

Study information

• Verified date: December 2009
• Source: Nanjing Medical University
• Contact: Yongqian Shu, MD
• Phone: 86 25 83718836
• Email: shuyongqian[@]csco.org.cn
• Is FDA regulated: No
• Health authority: China: JiangSu Health Bureau
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang University affiliated sir run run shaw hospital	HangZhou	Zhejiang
China	The 1st Affiliated Hospital Of NanJing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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, André T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DDC: Duration of Disease Control		Oct2012	Yes
Secondary	OS, RR, PFS, DCR, safety,		Oct 2015	Yes