Clinical Trials Logo
  1. Home
  2. Colorectal Carcinoma
  3. NCT02337946

Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Participants With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma — SAPPHIRE  

Colorectal Carcinoma Clinical Trial

Official title:
A Phase 2 Randomized Study Comparing the Efficacy and Safety of mFOLFOX6+Panitumumab Combination Therapy and 5-FU/LV+Panitumumab Combination Therapy in the Patients With Chemotherapy-Naive Unresectable Advanced Recurrent Colorectal Carcinoma of KRAS Wild-Type After 6 Cycles of Combination Therapy With mFOLFOX6+Panitumumab

Clinical Trial Summary

The purpose of this study is to exploratorily examine efficacy and safety in the participants with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of Kirsten rat sarcoma-2 virus (KRAS) wild-type who have been treated with 6 cycles (2 weeks/cycle) of first-line mFOLFOX6 + panitumumab combination therapy and then assigned to two groups i.e., a group receiving 5-FU/LV + panitumumab combination therapy and a group receiving mFOLFOX6 + panitumumab combination therapy.

Clinical Trial Description

The drug being tested in this study is called panitumumab. Panitumumab is being tested to treat people who have advanced/recurrent colorectal carcinoma of KRAS wild-type. This study will look at the efficacy and safety of 5-FU/LV + panitumumab(Pmab) combination therapy or mFOLFOX6 + Pmab combination therapy in the participants.

The study will enroll 164 patients. All participants will receive 6 cycles of Protocol Treatment [1]: Pmab 6 mg/kg, DIV, at Day 1, OXA 85 mg/m^2, DIV, at Day 1, l LV 200 mg/m^2, DIV, at Day 1, 5-FU 400 mg/m^2, IV, at Day 1, 5-FU 2400 mg/m^2, CIV, at Day 2 once every two weeks from cycle 1 through cycle 6.

Then they will be randomly assigned (by chance, like flipping a coin) to one of the treatment groups.

- Group A

- Group B

This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 20 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02337946
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date October 16, 2014
Completion date August 31, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT04444232 - Cancer Communication Within Hispanic Social Networks N/A
Recruiting NCT06233253 - Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy N/A
Recruiting NCT05799820 - QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC Phase 2
Recruiting NCT04666727 - Role of Diet on the Microbiome of the Digestive System
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Recruiting NCT02376452 - Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients Phase 2
Completed NCT02254486 - Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults Phase 3
Completed NCT01486251 - Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer N/A
Terminated NCT01233544 - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases Phase 3
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Completed NCT00704600 - Nelfinavir, a Phase I/Phase II Rectal Cancer Study Phase 1/Phase 2
Completed NCT00485316 - Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma Phase 3
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Terminated NCT02669914 - MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors Phase 2
Completed NCT05022511 - Three Birds With One Stone N/A
Not yet recruiting NCT03969784 - Microparticles in Peritoneal Carcinomatosis of Colorectal Origin N/A
Completed NCT04607291 - Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening Phase 1
Not yet recruiting NCT05630794 - Testing ONC201 to Prevent Colorectal Cancer Phase 1
Terminated NCT05291988 - A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial N/A
Suspended NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2