Phase Ib Study of Drozitumab Combined with First-Line mFOLFOX6 Plus Bevacizumab in Patients with Metastatic Colorectal Cancer

被引:33
|
作者
Lima, Caio M. Rocha [1 ,2 ]
Bayraktar, Soley [1 ,2 ]
Flores, Aurea M. [1 ,2 ]
MacIntyre, Jessica [1 ,2 ]
Montero, Alberto [1 ,2 ]
Baranda, Joaquina C. [3 ]
Wallmark, John [4 ]
Portera, Chia [5 ]
Raja, Rajiv [5 ]
Stern, Howard [5 ]
Royer-Joo, Stephanie [5 ]
Amler, Lukas C. [5 ]
机构
[1] Univ Miami, Div Hematol Oncol, Miami, FL 33136 USA
[2] Univ Miami Hosp & Clin, Sylvester Comprehens Canc Ctr, Miami, FL USA
[3] Univ Kansas, Med Ctr, Dept Med Oncol, Kansas City, KS 66103 USA
[4] Associates Oncol Hematol PC, Rockville, MD USA
[5] Genentech Inc, San Francisco, CA 94080 USA
关键词
Drozitumab; Metastatic colorectal cancer; Apo2; ligand; Apoptosis; Toxicity; Efficacy; CLINICAL-TRIALS; CHEMOTHERAPY;
D O I
10.3109/07357907.2012.732163
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
In this multicenter phase Ib study, drozitumab was given in combination with the mFOLFOX6 regimen and bevacizumab in patients with previously untreated, locally advanced recurrent or metastatic colorectal cancer on day 1 of every 14-day cycle. Nine patients were treated at 2 different cohort dose levels of drozitumab. No dose-limiting toxicities occurred at either dose level and the maximum tolerated dose was not reached. Two patients had a partial response of 4.93 and 4.96 months duration. Cohort 2 dose level is the recommended starting dose level for future trials.
引用
收藏
页码:727 / 731
页数:5
相关论文
共 50 条
  • [41] Phase I/II study of everolimus combined with mFOLFOX-6 and bevacizumab for first–line treatment of metastatic colorectal cancer
    G. Weldon Gilcrease
    David D. Stenehjem
    Mark L. Wade
    John Weis
    Kimberly McGregor
    Jonathan Whisenant
    Kenneth M. Boucher
    Kelli Thorne
    Nicole Orgain
    Ignacio Garrido-Laguna
    Sunil Sharma
    Investigational New Drugs, 2019, 37 : 482 - 489
  • [42] Phase I trial of erlotinib (E), modified FOLFOX6 (mFOLFOX6), and bevacizumab (B) as first-line therapy for metastatic colorectal cancer (MCRC)
    Singh, D.
    Rath, L.
    Bokar, J. A.
    Brell, J. M.
    Cooney, M. M.
    Dowlati, A.
    Gibbons, J.
    Nock, C. J.
    Savvides, P.
    Krishnamurthi, S. S.
    JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (15)
  • [43] Updated results from the multicenter phase II study of fruquintinib plus mFOLFOX6/FOLFIRI as first-line therapy in advanced metastatic colorectal cancer (mCRC)
    Zhou, F.
    Wang, W.
    Xia, L.
    Dai, J.
    Wu, H.
    Yang, L.
    Gong, J.
    Chen, X.
    Xiong, Z.
    Liang, X.
    ANNALS OF ONCOLOGY, 2023, 34 : S439 - S439
  • [44] Cetuximab is Associated With Excessive Toxicity When Combined With Bevacizumab Plus mFOLFOX6 in Metastatic Colorectal Carcinoma
    Ocean, Allyson J.
    Polite, Blase
    Christos, Paul
    Horvath, Lisa
    Hamilton, Anne
    Matulich, Daniel
    Chen, Helen X.
    Sparano, Joseph A.
    Kindler, Hedy L.
    CLINICAL COLORECTAL CANCER, 2010, 9 (05) : 290 - 296
  • [45] Results of a phase I study of andecaliximab in combination with mFOLFOX6 and bevacizumab in patients with previously untreated metastatic colorectal cancer
    Lenz, H-J.
    Park, H.
    Shah, M. A.
    Berlin, J. D.
    Bruetman, D.
    Chaves, J.
    Gordon, M.
    Patel, R.
    Starodub, A.
    Liu, J.
    Brachmann, C. Baker
    Bhargava, P.
    Wainberg, Z. A.
    Bendell, J.
    ANNALS OF ONCOLOGY, 2018, 29
  • [46] SUNITINIB PLUS 5-FLUOROURACIL, LEUCOVORIN AND OXALIPLATIN (MFOLFOX6) VS. BEVACIZUMAB PLUS MFOLFOX6 IN FRST-LINE METASTATIC COLORECTAL CANCER (MCRC) - INTERIM RESULTS OF A RANDOMIZED, PHASE IIB STUDY
    Hecht, J.
    Yoshino, T.
    Mitchell, E.
    Dees, M.
    Kroening, H.
    Patel, R.
    Welslau, M.
    Dakhil, S.
    Yamazaki, K.
    Maneval, Chow E.
    Kretzschmar, A.
    ANNALS OF ONCOLOGY, 2010, 21 : 15 - 15
  • [47] Bevacizumab plus XELOX as first-line therapy for patients with metastatic colorectal cancer
    Gaspar, E.
    Juarez Marroqui, A.
    Vicent, J.
    Llorca, C.
    Orts, D.
    Galan, A.
    Barrajon, E.
    Cervera Grau, J.
    Giner, V.
    Macia, S.
    JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (15)
  • [48] MFOLFOX6 plus CEDIRANIB VS MFOLFOX6 plus BEVACIZUMAB IN PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER (MCRC): A RANDOMIZED, DOUBLE-BLIND, PHASE II/III STUDY (HORIZON III)
    Schmoll, H.
    Cunningham, D.
    Sobrero, A.
    Karapetis, C.
    Rougier, P.
    Koski, S. L.
    Barker, P.
    Mookerjee, B.
    Robertson, J.
    van Cutsem, E.
    ANNALS OF ONCOLOGY, 2010, 21 : 189 - 189
  • [49] A randomized phase II study of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab for previously untreated, liver-limited metastatic colorectal cancer that is unsuitable for resection (ATOM trial).
    Uetake, Hiroyuki
    Emi, Yasunori
    Yamanaka, Takeharu
    Muro, Kei
    Oki, Eiji
    Takahashi, Takao
    Nagasaka, Takeshi
    Hatano, Etsuro
    Ojima, Hitoshi
    Manaka, Dai
    Kusumoto, Tetsuya
    Katayose, Yu
    Fujiwara, Toshiyoshi
    Yoshida, Kazuhiro
    Unno, Michiaki
    Hyodo, Ichinosuke
    Tomita, Naohiro
    Sugihara, Kenichi
    Maehara, Yoshihiko
    JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (04)
  • [50] First-line panitumumab versus bevacizumab in combination with mFOLFOX6 for RAS wild-type metastatic colorectal cancer: PARADIGM trial results
    Muro, K.
    Watanabe, J.
    Shitara, K.
    Yamazaki, K.
    Ohori, H.
    Shiozawa, M.
    Yasui, H.
    Oki, E.
    Sato, T.
    Naitoh, T.
    Komatsu, Y.
    Kato, T.
    Hihara, M.
    Soeda, J.
    Yamamoto, K.
    Akagi, K.
    Ochiai, A.
    Uetake, H.
    Yoshino, T.
    ANNALS OF ONCOLOGY, 2022, 33 : S377 - S377