Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT02337946
Conditions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Nagakute, Aichi, Japan
, Nagoya, Aichi, Japan
, Okazaki, Aichi, Japan
, Toyoaki, Aichi, Japan
, Yachiyo, Chiba, Japan
, Kitakyushu, Fukuoka, Japan
, Tagawa, Fukuoka, Japan
, Aizuwakamatsu, Fukushima, Japan
, Kakamigahara, Gifu, Japan
, Tajimi, Gifu, Japan
, Hakodate, Hokkaido, Japan
, Kushiro, Hokkaido, Japan
, Amagasaki, Hyogo, Japan
, Kakogawa, Hyogo, Japan
, Kobe, Hyogo, Japan
, Nishinomiya, Hyogo, Japan
, Kahoku, Ishikawa, Japan
, Kanazawa, Ishikawa, Japan
, Morioka, Iwate, Japan
, Kida-gun, Kagawa, Japan
, Marugame, Kagawa, Japan
, Takamatsu, Kagawa, Japan
, Kawasaki, Kanagawa, Japan
, Yokohama, Kanagawa, Japan
, Nangoku, Kochi, Japan
, Sendai, Miyagi, Japan
, Matsumoto, Nagano, Japan
, Suwa, Nagano, Japan
, Sasebo, Nagasaki, Japan
, Higashiosaka, Osaka, Japan
, Hirakata, Osaka, Japan
, Izumisano, Osaka, Japan
, Izumi, Osaka, Japan
, Sakai, Osaka, Japan
, Tondabayashi, Osaka, Japan
, Hidaka, Saitama, Japan
, Izumo, Shimane, Japan
, Fujioka, Shizuoka, Japan
, Shimonoseki, Yamaguchi, Japan
, Akita, , Japan
, Fukui, , Japan
, Fukuoka, , Japan
, Gifu, , Japan
, Hiroshima, , Japan
, Kyoto, , Japan
, Nagasaki, , Japan
, Okinawa, , Japan
, Osaka, , Japan
, Saga, , Japan
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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