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Baer A.R.,American Society of Clinical Oncology | Baer A.R.,Northern Indiana Cancer Research Consortium | Baer A.R.,Hospital for Sick Children | Baer A.R.,Missouri Baptist Cancer Center | And 12 more authors.
Journal of Oncology Practice | Year: 2011

Developing and maintaining an exemplary research team is essential to the success of a quality clinical research program. Functions such as regulatory compliance, protocol maintenance, patient care, tissue acquisition and transmittal, data collection and submission, and general administration are among the many tasks on which quality clinical research, protection of subjects' rights, and advancement of science depend. No single individual could expect to fulfill all of these tasks. Effective management requires shared commitment to excellence, mutual respect for each team member's role, and effective communication. Once staff members are trained and data management systems are implemented, this infrastructure has to be maintained and refreshed continually. Ultimately, a leader of an effective research program must acknowledge the value of each of its members while promoting a culture of teamwork and commitment to delivering high-quality care to patients. Copyright © 2011 by American Society of Clinical Oncology.

Northfelt D.W.,Mayo Clinic Arizona | Allred J.B.,Research Services | Liu H.,Research Services | Hobday T.J.,Mayo Medical School | And 3 more authors.
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2014

Background: Capecitabine and paclitaxel are established effective treatments, alone and combined with other cytotoxic and targeted agents, for metastatic breast cancer (MBC). Paclitaxel polyglumex (a macromolecular conjugate of paclitaxel bound to poly-L-glutamic acid) has potential advantages over conventional paclitaxel, including little alopecia, short infusion time with no premedication, enhanced tumor permeability/retention effect, and improved tolerability. We therefore examined tolerability and efficacy of paclitaxel polyglumex with capecitabine in patients with MBC. Patients and Methods: This was a single-stage phase 2 study, with interim analysis conducted with endpoints of tumor response, adverse events (toxicities), time to progression, and overall survival. The main eligibility criteria were: age >18 years, no prior MBC chemotherapy, Eastern Cooperative Oncology Group performance score <2, disease measurable by RECIST criteria, no HER2 overexpression or amplification, no brain metastases or peripheral sensory neuropathy. Treatment consisted of paclitaxel polyglumex (135 mg/m2) by intravenous infusion on day 1 + capecitabine (825 mg/m2) orally twice daily on days 1 to 14, repeated on a 3-week cycle. Forty-one evaluable patientswere equired to test the null hypothesis that the complete and partial tumor response rate (CR + PR) was at the most 40% against the alternative of at least 60%. Paclitaxel polyglumex + capecitabine would be considered promising in this population if Z21 responses were observed among first 41 evaluable patients. Results: Forty-eight patients were enrolled between April 2006 and April 2007; all patients were evaluable. The median number of treatment cycles administered was 6. Eighteen patients [38%; 95% confidence interval (CI), 24%-53%] had a confirmed tumor response (2 CR, 16 PR) by RECIST criteria. Fifteen (38%; 95% CI, 23%-53%) responses occurred in first 41 patients, falling short of prespecified goal of 21 responses. Median duration of tumor response was 13.2 months. Three of the responders were progression free at last follow-up with a median follow-up of 43 months. Median progression-free survival was 5.1 months (95% CI, 4.0-7.6 mo). Six-month progression-free survival was 42% (95% CI, 30%-58%). Median dose level administered was paclitaxel polyglumex (135 mg/m2) and capecitabine (825 mg/m2) for cycles 1 to 7. Most common severe (grade 3/4) toxicities (at least possibly related to study drug) were: leukopenia 9 (19%), neutropenia 8 (17%), neurosensory 4 (8%), skin reaction-hand/foot 4 (8%), and dyspnea 2 (4%). Forty-six percent (22/47) of patients experienced grade Z3 toxicity and 8% (4/48) experienced grade Z4 toxicity. No alopecia was reported. Conclusions: Although the trial failed to reach goal of 21 confirmed tumor responses among the first 41 evaluable patients, paclitaxel polyglumex and capecitabine is well tolerated and effective in MBC. Copyright © 2012 by Lippincott Williams & Wilkins.

Adjei A.A.,Roswell Park Cancer Institute | Dy G.K.,Roswell Park Cancer Institute | Mandrekar S.J.,Mayo Medical School | Nelson G.D.,Mayo Medical School | And 7 more authors.
Journal of Thoracic Oncology | Year: 2013

INTRODUCTION: The purpose of this study was to assess the safety and efficacy of gemcitabine and carboplatin with (arm A) or without (arm B) daily oral cediranib as first-line therapy for advanced non-small-cell lung cancer. METHODS: A lead-in phase to determine the tolerability of gemcitabine 1000 mg/m on days 1 and 8, and carboplatin on day 1 at area under curve 5 administered every 21 days with cediranib 45 mg once daily was followed by a 2 (A):1 (B) randomized phase II study. The primary end point was confirmed overall response rate (ORR) with 6-month progression-free survival (PFS6) rate in arm A as secondary end point. Polymorphisms in genes encoding cediranib targets and transport were correlated with treatment outcome. RESULTS: On the basis of the safety assessment, cediranib 30 mg daily was used in the phase II portion. A total of 58 and 29 evaluable patients were accrued to arms A and B. Patients in A experienced more grade 3+ nonhematologic adverse events, 71% versus 45% (p = 0.01). The ORR was 19% (A) versus 20% (B) (p = 1.0). PFS6 in A was 48% (95% confidence interval: 35%-62%), thus meeting the protocol-specified threshold of at least 40%. The median overall survival was 12.0 versus 9.9 months (p = 0.10). FGFR1 rs7012413, FGFR2 rs2912791, and VEGFR3 rs11748431 polymorphisms were significantly associated with decreased overall survival (hazard ratio 2.78-5.01, p = 0.0002-0.0095). CONCLUSIONS: The trial did not meet its primary end point of ORR but met its secondary end point of PFS6. The combination with cediranib 30 mg daily resulted in increased toxicity. Pharmacogenetic analysis revealed an association of FGFR and VEGFR variants with survival. Copyright © 2012 by the International Association for the Study of Lung Cancer.

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