A phase II evaluation of nintedanib (BIBF-1120) in the treatment of recurrent or persistent endometrial cancer: An NRG Oncology/Gynecologic Oncology Group Study

Gynecologic Oncology

Volumn 135, Issue 3, 2014, Pages 441-445

  Dizon, Don S ^a   Sill, Michael W ^b   Schilder, Jeanne M ^c   McGonigle, Kathryn F ^d   Rahman, Zia ^e   Miller, David S ^f   Mutch, David G ^g   Leslie, Kimberly K ^h  

^a HARVARD MEDICAL SCHOOL   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c INDIANA UNIVERSITY   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

^e SAINT FRANCIS HOSPITAL AND MEDICAL CENTER   (United States)

^f UNIVERSITY OF TEXAS AT DALLAS   (United States)

^g WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

Author keywords

Angiogenesis inhibitor; Clinical trial; Endometrial cancer

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; NINTEDANIB; ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; APPLICATION SITE REACTION; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BREAST DISEASE; CANCER CHEMOTHERAPY; CANCER PAIN; CANCER PATIENT; CANCER RECURRENCE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED ANEMIA; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; EDEMA; ENDOMETRIUM CANCER; EVENT FREE SURVIVAL; FEMALE; FLATULENCE; GASTRITIS; GASTROINTESTINAL TOXICITY; HEART DISEASE; HEPATOBILIARY DISEASE; HUMAN; HYPERTENSION; INTESTINE DISTENSION; KIDNEY DISEASE; LEUKOPENIA; LIVER DYSFUNCTION; MENTAL DISEASE; METABOLIC DISORDER; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NEUTROPENIA; NUTRITIONAL DISORDER; OVERALL SURVIVAL; PERFORATION; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REPRODUCTIVE TOXICITY; RESPIRATORY TRACT DISEASE; SENSORY NEUROPATHY; SINGLE DRUG DOSE; SKIN DISEASE; SUBCUTANEOUS FAT DISORDER; THORAX DISEASE; THROMBOCYTOPENIA; TREATMENT RESPONSE; URINARY TRACT DISEASE; VASCULAR DISEASE; VERY ELDERLY; XEROSTOMIA; CLINICAL TRIAL; DISEASE FREE SURVIVAL; ENDOMETRIAL NEOPLASMS; MULTICENTER STUDY; PATHOLOGY; TUMOR RECURRENCE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; ENDOMETRIAL NEOPLASMS; FEMALE; HUMANS; INDOLES; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL;

EID: 84920741562     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2014.10.001     Document Type: Article

References (14)

1. Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics. CA Cancer J Clin 2014;64:9-29.
2. Weidner N, Folkman J. Tumoral vascularity as a prognostic factor in cancer. Important Adv Oncol 1996:167-90.
3. Carmeliet P. Mechanisms of angiogenesis and arteriogenesis. Nat Med 2000;6:389-95.
4. McMeekin DS, Sill MW, Darcy KM, Stearns-Kurosawa DJ, Webster K, Waggoner S, et al. A phase II trial of thalidomide in patients with refractory endometrial cancer and correlation with angiogenesis biomarkers: a Gynecologic Oncology Group study. Gynecol Oncol 2007;105:508-16.
5. Toi M, Matsumoto T, Bando H. Vascular endothelial growth factor: its prognostic, predictive, and therapeutic implications. Lancet Oncol 2001;2:667-73.
6. Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, et al. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol 2011;29:2259-65.
7. Coleman RL, Sill MW, Lankes HA, Fader AN, Finkler NJ, Hoffman JS, et al. A phase II evaluation of aflibercept in the treatment of recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. Gynecol Oncol 2012;127:538-43.
8. Pollock PM, Gartside MG, Dejeza LC, Powell MA, Mallon MA, Davies H, et al. Frequent activating FGFR2 mutations in endometrial carcinomas parallel germline mutations associated with craniosynostosis and skeletal dysplasia syndromes. Oncogene 2007;26:7158-62.
9. Powell MA, Sill MW, Goodfellow PJ. A phase II trial of brivanib in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. Int J Gynecol Cancer 2012;22(Suppl. 3):E115.
10. LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer - Full Text View - ClinicalTrials.gov. at. http://clinicaltrials.gov/ct2/show/NCT01015118?term=nintedanib%2C+ovarian+cancer&rank=5.
11. Du Bois A, Kristensen G, Ray-Coquard I, et al. AGO-OVAR 12: A randomized controlled GCIG/ENGOT-intergroup phase III trial of standard frontline chemotherapy +/- nintedanib for advanced ovarian cancer. Int J Gynecol Cancer 2013;23(8 (Suppl. 1)):7-8.
12. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-47.
13. Sill MW, Rubinstein L, Litwin S, Yothers G. A method for utilizing co-primary efficacy outcome measures to screen regimens for activity in two-stage Phase II clinical trials. Clin Trials Lond Engl 2012;9:385-95.
14. Meng X, Dizon DS, Yang S, Wang X, Zhu D, Thiel KW, et al. Strategies for molecularly enhanced chemotherapy to achieve synthetic lethality in endometrial tumors with mutant p53. Obstet Gynecol Int 2013;828165.