American Society of Clinical Oncology Policy Statement Update: the Critical Role of Phase I Trials in Cancer Research and Treatment

Overview

Journal J Clin Oncol

Specialty Oncology

Date 2014 Dec 17

PMID 25512456

Citations 47

Authors

Jeffrey S Weber

Laura A Levit

Peter C Adamson

Suanna Bruinooge

Howard A Burris 4th

Michael A Carducci

Adam P Dicker

Mithat Gonen

Stephen M Keefe

Michael A Postow

Michael A Thompson

David M Waterhouse

Susan L Weiner

Lynn M Schuchter

Affiliations

Soon will be listed here.

Citing Articles

SEETrials: Leveraging large language models for safety and efficacy extraction in oncology clinical trials.

Lee K, Paek H, Huang L, Hilton C, Datta S, Higashi J Inform Med Unlocked. 2024; 50.

PMID: 39493413 PMC: 11530223. DOI: 10.1016/j.imu.2024.101589.

Letter to the Editor of Annals of Surgical Oncology Concerning "Safety and Efficacy of Oxaliplatin Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Colorectal and Appendiceal Cancer with Peritoneal Metastases: Results of a Multicenter....

Chiu C Ann Surg Oncol. 2023; 31(4):2405-2407.

PMID: 37971615 DOI: 10.1245/s10434-023-14595-w.

Everolimus in combination with vandetanib in children, adolescents, and young adults: a phase I study.

Phadnis S, Wang X, Daw N, Herzog C, Subbiah I, Zaky W ESMO Open. 2023; 8(6):101609.

PMID: 37879233 PMC: 10774869. DOI: 10.1016/j.esmoop.2023.101609.

Principal Investigators' Perceptions on Factors Associated with Successful Recruitment in Clinical Trials.

Idnay B, Butler A, Fang Y, Li Z, Lee J, Ta C AMIA Jt Summits Transl Sci Proc. 2023; 2023:281-290.

PMID: 37350899 PMC: 10283115.

A pilot randomized study of a telephone-based cognitive-behavioral stress-management intervention to reduce distress in phase 1 oncology trial caregivers.

Carr A, Bilenduke E, Adolf E, Kessler E, Arch J, Ranby K Palliat Support Care. 2023; 21(5):820-828.

PMID: 36994841 PMC: 10544682. DOI: 10.1017/S1478951523000196.

References

Kircher S, Benson 3rd A, Farber M, Nimeiri H . Effect of the accountable care act of 2010 on clinical trial insurance coverage. J Clin Oncol. 2011; 30(5):548-53. DOI: 10.1200/JCO.2011.37.8190. View

Frei 3rd E . Clinical trials of antitumor agents: experimental design and timeline considerations. Cancer J Sci Am. 1997; 3(3):127-36. View

Camidge D, Bang Y, Kwak E, Iafrate A, Varella-Garcia M, Fox S . Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol. 2012; 13(10):1011-9. PMC: 3936578. DOI: 10.1016/S1470-2045(12)70344-3. View

Sulmasy D, Astrow A, He M, Seils D, Meropol N, Micco E . The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer. 2010; 116(15):3702-11. PMC: 3644988. DOI: 10.1002/cncr.25201. View

Horstmann E, McCabe M, Grochow L, Yamamoto S, Rubinstein L, Budd T . Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005; 352(9):895-904. DOI: 10.1056/NEJMsa042220. View

Creemers G, Bolis G, Gore M, Scarfone G, Lacave A, Guastalla J . Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study. J Clin Oncol. 1996; 14(12):3056-61. DOI: 10.1200/JCO.1996.14.12.3056. View

Garre M, Gandus S, Cesana B, Haupt R, De Bernardi B, Comelli A . Health status of long-term survivors after cancer in childhood. Results of an uniinstitutional study in Italy. Am J Pediatr Hematol Oncol. 1994; 16(2):143-52. View

Roberts Jr T, Goulart B, Squitieri L, Stallings S, Halpern E, Chabner B . Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA. 2004; 292(17):2130-40. DOI: 10.1001/jama.292.17.2130. View

Geenen M, Cardous-Ubbink M, Kremer L, van den Bos C, van der Pal H, Heinen R . Medical assessment of adverse health outcomes in long-term survivors of childhood cancer. JAMA. 2007; 297(24):2705-15. DOI: 10.1001/jama.297.24.2705. View

10.

Estey E, Hoth D, Simon R, Marsoni S, Leyland-Jones B, Wittes R . Therapeutic response in phase I trials of antineoplastic agents. Cancer Treat Rep. 1986; 70(9):1105-15. View

11.

Italiano A, Massard C, Bahleda R, Vataire A, Deutsch E, Magne N . Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy. Ann Oncol. 2007; 19(4):787-92. DOI: 10.1093/annonc/mdm548. View

12.

Francis R, Sharma S, Springer C, Green A, Sena L, Martin J . A phase I trial of antibody directed enzyme prodrug therapy (ADEPT) in patients with advanced colorectal carcinoma or other CEA producing tumours. Br J Cancer. 2002; 87(6):600-7. PMC: 2364249. DOI: 10.1038/sj.bjc.6600517. View

13.

Cox K . Enhancing cancer clinical trial management: recommendations from a qualitative study of trial participants' experiences. Psychooncology. 2000; 9(4):314-22. DOI: 10.1002/1099-1611(200007/08)9:4<314::aid-pon464>3.0.co;2-c. View

14.

Babb J, Rogatko A, Zacks S . Cancer phase I clinical trials: efficient dose escalation with overdose control. Stat Med. 1998; 17(10):1103-20. DOI: 10.1002/(sici)1097-0258(19980530)17:10<1103::aid-sim793>3.0.co;2-9. View

15.

Agrawal M, Emanuel E . Ethics of phase 1 oncology studies: reexamining the arguments and data. JAMA. 2003; 290(8):1075-82. DOI: 10.1001/jama.290.8.1075. View

16.

Ratain M . Targeted therapies: redefining the primary objective of phase I oncology trials. Nat Rev Clin Oncol. 2014; 11(9):503-4. DOI: 10.1038/nrclinonc.2014.135. View

17.

Carlson L, Bultz B, Morris D . Individualized quality of life, standardized quality of life, and distress in patients undergoing a phase I trial of the novel therapeutic Reolysin (reovirus). Health Qual Life Outcomes. 2005; 3:7. PMC: 548292. DOI: 10.1186/1477-7525-3-7. View

18.

Tsimberidou A, Iskander N, Hong D, Wheler J, Falchook G, Fu S . Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative. Clin Cancer Res. 2012; 18(22):6373-83. PMC: 4454458. DOI: 10.1158/1078-0432.CCR-12-1627. View

19.

Berdel W, Knopf H, Fromm M, Schick H, Busch R, Fink U . Influence of phase I early clinical trials on the quality of life of cancer patients. A pilot study. Anticancer Res. 1988; 8(3):313-21. View

20.

Smith T, Temin S, Alesi E, Abernethy A, Balboni T, Basch E . American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care. J Clin Oncol. 2012; 30(8):880-7. DOI: 10.1200/JCO.2011.38.5161. View