An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer

NCT ID: NCT02394834

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 757 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-29
• Study Completion Date: 2026-03-31

Brief Summary

The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Detailed Description

The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + mFOLFOX (PARADIGM Study: NCT02394795) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group P; mFOLFOX6 + panitumumab combination therapy

OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab

Intervention Type: DRUG

oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Group B; mFOLFOX6 + bevacizumab combination therapy

OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab

Intervention Type: DRUG

oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Interventions

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab

oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Intervention Type: DRUG

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab

oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

(1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study

Exclusion Criteria

(1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Ichinomiya, Aichi-ken, Japan

Komaki, Aichi-ken, Japan

Kounan, Aichi-ken, Japan

Nagakute, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Okazaki, Aichi-ken, Japan

Toyohashi, Aichi-ken, Japan

Toyokawa, Aichi-ken, Japan

Toyota, Aichi-ken, Japan

Yatomi, Aichi-ken, Japan

Daisen, Akita, Japan

Hirosaki, Aomori, Japan

Misawa, Aomori, Japan

Kashiwa, Chiba, Japan

Yachiyo, Chiba, Japan

Matsuyama, Ehime, Japan

Tōon, Ehime, Japan

Tsuruga, Fukui, Japan

Yoshida, Fukui, Japan

Kitakyushu, Fukuoka, Japan

Koga, Fukuoka, Japan

Koga, Fukuoka, Japan

Kurume, Fukuoka, Japan

Omuta, Fukuoka, Japan

Aizu-Wakamatsu, Fukushima, Japan

Iwaki, Fukushima, Japan

Kōriyama, Fukushima, Japan

Shirakawa, Fukushima, Japan

Hashima, Gifu, Japan

Kakamigahara, Gifu, Japan

Minokamo, Gifu, Japan

Okazai, Gifu, Japan

Ōgaki, Gifu, Japan

Maebashi, Gunma, Japan

Ōta, Gunma, Japan

Fukuyama, Hiroshima, Japan

Hakodate, Hokkaido, Japan

Kitami, Hokkaido, Japan

Kushiro, Hokkaido, Japan

Obihiro, Hokkaido, Japan

Otaru, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Akashi, Hyōgo, Japan

Amagasaki, Hyōgo, Japan

Himeji, Hyōgo, Japan

Kobe, Hyōgo, Japan

Nishinomiya, Hyōgo, Japan

Hitachi, Ibaraki, Japan

Kasama, Ibaraki, Japan

Ryūgasaki, Ibaraki, Japan

Tsuchiura, Ibaraki, Japan

Tsukuba, Ibaraki, Japan

Hakusan, Ishikawa-ken, Japan

Kaga, Ishikawa-ken, Japan

Kahoku, Ishikawa-ken, Japan

Kanazawa, Ishikawa-ken, Japan

Nanao, Ishikawa-ken, Japan

Morioka, Iwate, Japan

Kida, Kagawa-ken, Japan

Marugame, Kagawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Fujisawa, Kanagawa, Japan

Hiratsuka, Kanagawa, Japan

Isehara, Kanagawa, Japan

Kamakura, Kanagawa, Japan

Kanazawachō, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka, Kanagawa, Japan

Nankoku, Kochi, Japan

Matsuzaka, Mie-ken, Japan

Tsu, Mie-ken, Japan

Yokkaichi, Mie-ken, Japan

Ishinomaki, Miyagi, Japan

Murata, Miyagi, Japan

Natori-shi, Miyagi, Japan

Ōsaki, Miyagi, Japan

Sendai, Miyagi, Japan

Matsumoto, Nagano, Japan

Saku, Nagano, Japan

Ōmura, Nagasaki, Japan

Sasebo, Nagasaki, Japan

Ikoma, Nara, Japan

Tenri, Nara, Japan

Yamatotakada, Nara, Japan

Yufu, Oita Prefecture, Japan

Kurashiki, Okayama-ken, Japan

Naha, Okinawa, Japan

Tomigusuku, Okinawa, Japan

Urasoe, Okinawa, Japan

Hirakata, Osaka, Japan

Kawachi-Nagano, Osaka, Japan

Moriguchi, Osaka, Japan

Neyagawa, Osaka, Japan

Sayama, Osaka, Japan

Suita, Osaka, Japan

Takatsuki, Osaka, Japan

Kawagoe, Saitama, Japan

Kitaadachi, Saitama, Japan

Koshigaya, Saitama, Japan

Moriyama, Shiga, Japan

Ōtsu, Shiga, Japan

Izumi, Shimane, Japan

Izumo, Shimane, Japan

Hamamatsu, Shizuoka, Japan

Izunokuni, Shizuoka, Japan

Sunto, Shizuoka, Japan

Shimotsuga, Tochigi, Japan

Shimotsuke, Tochigi, Japan

Utsunomiya, Tochigi, Japan

Komatsushimachō, Tokushima, Japan

Bunkyo-ku, Tokyo, Japan

Chiyoda-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Koto-ku, Tokyo, Japan

Machida, Tokyo, Japan

Minato-ku, Tokyo, Japan

Musashino, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjyuku-ku, Tokyo, Japan

Yonago, Tottori, Japan

Kurobe-shi, Toyama, Japan

Takaoka, Toyama, Japan

Sakata, Yamagata, Japan

Tsuruoka, Yamagata, Japan

Iwakuni, Yamaguchi, Japan

Kofu, Yamanashi, Japan

Akita, , Japan

Aomori, , Japan

Chiba, , Japan

Fukui, , Japan

Fukuoka, , Japan

Gifu, , Japan

Kagoshima, , Japan

Kochi, , Japan

Kumamoto, , Japan

Kyoto, , Japan

Miyazaki, , Japan

Nagano, , Japan

Nagasaki, , Japan

Niigata, , Japan

Okayama, , Japan

Okinawa, , Japan

Osaka, , Japan

Saga, , Japan

Saitama, , Japan

Shizuoka, , Japan

Tokushima, , Japan

Toyama, , Japan

Yamagata, , Japan

Countries

Japan

References

Shitara K, Muro K, Watanabe J, Yamazaki K, Ohori H, Shiozawa M, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Mori I, Yamanaka K, Hihara M, Soeda J, Misumi T, Yamamoto K, Yamashita R, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Baseline ctDNA gene alterations as a biomarker of survival after panitumumab and chemotherapy in metastatic colorectal cancer. Nat Med. 2024 Mar;30(3):730-739. doi: 10.1038/s41591-023-02791-w. Epub 2024 Feb 12.

Reference Type: DERIVED

PMID: 38347302 (View on PubMed)

Yoshino T, Uetake H, Tsuchihara K, Shitara K, Yamazaki K, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Yamanaka K, Iwasaki K, Soeda J, Hihara M, Yamanaka T, Ochiai A, Muro K. Rationale for and Design of the PARADIGM Study: Randomized Phase III Study of mFOLFOX6 Plus Bevacizumab or Panitumumab in Chemotherapy-naive Patients With RAS (KRAS/NRAS) Wild-type, Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2017 Jun;16(2):158-163. doi: 10.1016/j.clcc.2017.01.001. Epub 2017 Jan 24.

Reference Type: DERIVED

PMID: 28237539 (View on PubMed)

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b60294db2bf003ab499d5

To obtain more information on the study, click here/on this link

Other Identifiers

U1111-1167-3521

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT1080222785

Identifier Type: REGISTRY

Identifier Source: secondary_id

UMIN000016782

Identifier Type: REGISTRY

Identifier Source: secondary_id

Panitumumab-4004

Identifier Type: -

Identifier Source: org_study_id