2022
Randomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011).
Sonpavde G, Plets M, Liss M, Meeks J, Petrylak D, Cole S, McKay R, Gupta S, Hita S, Pereira T, Bangs R, Tangen C, Thompson I, Lerner S. Randomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011). Journal Of Clinical Oncology 2022, 40: tps591-tps591. DOI: 10.1200/jco.2022.40.6_suppl.tps591.Peer-Reviewed Original ResearchMuscle-invasive urothelial carcinomaMuscle-invasive bladder cancerUpper tract urothelial carcinomaImmune checkpoint inhibitorsWeeks x 4 cyclesPathologic complete remissionEvent-free survivalPhase II trialUpfront surgeryUrothelial carcinomaDay 1II trialNeoadjuvant therapyOverall survivalHigh-risk upper tract urothelial carcinomaCisplatin-ineligible metastatic urothelial carcinomaNeoadjuvant cisplatin-based combination chemotherapyOpen-label phase II trialHigh grade upper tract urothelial carcinomaNeoadjuvant immune checkpoint inhibitorsRandomized phase II trialCisplatin-based combination chemotherapyCisplatin-eligible patientsMetastatic urothelial carcinomaPD-L1 inhibitors
2016
IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC).
Hoffman-Censits J, Grivas P, Van Der Heijden M, Dreicer R, Loriot Y, Retz M, Vogelzang N, Perez-Gracia J, Rezazadeh A, Bracarda S, Yu E, Hoimes C, Bellmunt J, Quinn D, Petrylak D, Hussain S, Cui N, Mariathasan S, Abidoye O, Rosenberg J. IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2016, 34: 355-355. DOI: 10.1200/jco.2016.34.2_suppl.355.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPoor prognostic factorPrognostic factorsPD-L1Prognostic subgroupsPD-L1/PDImmune cell statusMedian treatment durationPD-L1 subgroupsTreatment-related AEsPD-L1 expressionPD-L1 statusPhase II trialPlatinum-based chemotherapyCo-primary endpointsPoor prognostic subgroupMUC patientsRECIST v1.1Data cutoffDurable responsesII trialAntitumor immunityG3-4Median ageHistoric controls
2014
A phase II trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Smith D, Appleman L, Fleming M, Hussain A, Dreicer R, Sartor A, Shore N, Vogelzang N, Youssoufian H, Olson W, Stambler N, Huang K, Israel R. A phase II trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: 83-83. DOI: 10.1200/jco.2014.32.4_suppl.83.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenProgressive metastatic castration-resistant prostate cancerProstate-specific antigenCastration-resistant prostate cancerMonomethyl auristatin EPhase II trialAdverse eventsII trialTumor responseProstate cancerECOG PS 0Significant adverse eventsAntibody drugsFree MMAEHigh PSMA expressionAnti-tumor activityProstate cancer cellsCTC declinePrior docetaxelPSA declinePS 0Peripheral neuropathyPSA reductionAntibody therapy
2012
Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy.
Pond G, Sonpavde G, Choueiri T, Qu A, Vaughn D, Fougeray R, Niegisch G, Albers P, Wong Y, Ko Y, Sridhar S, Galsky M, Petrylak D, Beer T, Stadler W, O'Donnell P, Sternberg C, Rosenberg J, Molins J. Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy. Journal Of Clinical Oncology 2012, 30: 4522-4522. DOI: 10.1200/jco.2012.30.15_suppl.4522.Peer-Reviewed Original ResearchSecond-line therapyAdvanced urothelial carcinomaMedian overall survivalOverall survivalPrior chemotherapyUrothelial carcinomaLiver metastasesPerformance statusPrognostic factorsSecond-line systemic therapyOptimal cutpointSignificant negative prognostic impactECOG performance statusFirst study treatmentSecond-line chemotherapyPhase II trialKaplan-Meier methodNegative prognostic impactProportional hazards regressionLikelihood ratio χBaseline HbII trialMetastatic diseaseOS independentPrognostic impactCorrelation of progression-free survival at 6 months (PFS6) with overall survival at 12 months (OS12) in an analysis of 10 trials of second-line therapy for advanced urothelial carcinoma (UC).
Maughan B, Boucher K, Agarwal N, Choueiri T, Qu A, Vogelzang N, Fougeray R, Niegisch G, Albers P, Wong Y, Ko Y, Sridhar S, Galsky M, Petrylak D, Vaishampayan U, Beer T, Sternberg C, Rosenberg J, Molins J, Sonpavde G. Correlation of progression-free survival at 6 months (PFS6) with overall survival at 12 months (OS12) in an analysis of 10 trials of second-line therapy for advanced urothelial carcinoma (UC). Journal Of Clinical Oncology 2012, 30: 4525-4525. DOI: 10.1200/jco.2012.30.15_suppl.4525.Peer-Reviewed Original ResearchSecond-line therapyAdvanced urothelial carcinomaPhase II trialUrothelial carcinomaIndividual-level agreementResponse rateII trialIndividual patient progressionProgression-free survivalAssociation of responsePearson's chi-square testDuration of benefitSignificant unmet needRandom-effects modelChi-square testPearson correlationPrimary endpointVisceral metastasesOverall survivalPerformance statusMedian ageYates' continuity correctionPatient progressionIntermediate endpointsPFS61769 UPDATED RESULTS OF THE COMBINED PHASE I/II TRIAL OF INTRAVESICAL NANOPARTICLE ALBUMIN-BOUND PACLITAXEL IN THE TREATMENT OF BCG REFRACTORY NON-MUSCLE INVASIVE TRANSITIONAL CELL CARCINOMA
McKiernan J, Holder D, Kates M, Badalato G, Barlow L, RoyChoudhury A, Petrylak D, Benson M. 1769 UPDATED RESULTS OF THE COMBINED PHASE I/II TRIAL OF INTRAVESICAL NANOPARTICLE ALBUMIN-BOUND PACLITAXEL IN THE TREATMENT OF BCG REFRACTORY NON-MUSCLE INVASIVE TRANSITIONAL CELL CARCINOMA. Journal Of Urology 2012, 187: e714. DOI: 10.1016/j.juro.2012.02.1786.Peer-Reviewed Original Research1666 SWOG S0353 PHASE II TRIAL OF INTRAVESICAL GEMCITABINE IN PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER WHO RECURRED FOLLOWING AT LEAST TWO PRIOR COURSES OF BCG
Skinner E, Goldman B, Sakr W, Petrylak D, Lenz H, Lee C, Wilson S, Lerner S, Tangen C, Thompson I. 1666 SWOG S0353 PHASE II TRIAL OF INTRAVESICAL GEMCITABINE IN PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER WHO RECURRED FOLLOWING AT LEAST TWO PRIOR COURSES OF BCG. Journal Of Urology 2012, 187: e673. DOI: 10.1016/j.juro.2012.02.1524.Peer-Reviewed Original ResearchRandomized phase II trial of maintenance sunitinib versus placebo following response to chemotherapy (CT) for patients (pts) with advanced urothelial carcinoma (UC).
Grivas P, Nanus D, Stadler W, Daignault S, Dreicer R, Kohli M, Petrylak D, Vaughn D, Bylow K, Belldegrun A, Sottnik J, Keller E, Smith D, Hussain M. Randomized phase II trial of maintenance sunitinib versus placebo following response to chemotherapy (CT) for patients (pts) with advanced urothelial carcinoma (UC). Journal Of Clinical Oncology 2012, 30: 265-265. DOI: 10.1200/jco.2012.30.5_suppl.265.Peer-Reviewed Original ResearchOpen-label sunitinibAdvanced urothelial carcinomaUrothelial carcinomaMaintenance sunitinibProgression rateResponse rateMedian age 69 yearsRandomized phase II trialAdequate organ functionECOG PS 0ECOG PS 1Objective response rateCycles of chemotherapyVEGF/Age 69 yearsPhase II trialSerum level changesProgression of UCMedian TTPSecondary endpointsStable diseaseII trialOral sunitinibPS 0Complete response
2009
A combined phase I/II trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of refractory non–muscle- invasive transitional cell bladder cancer
Barlow L, Laudano M, Mann M, Desai M, Petrylak D, Benson M, McKiernan J. A combined phase I/II trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of refractory non–muscle- invasive transitional cell bladder cancer. Journal Of Clinical Oncology 2009, 27: e16047-e16047. DOI: 10.1200/jco.2009.27.15_suppl.e16047.Peer-Reviewed Original ResearchPhase I trialPhase I/II trialIntravesical agentsNab-paclitaxelI trialII trialIntravesical therapyBladder cancerSystemic absorptionInvasive transitional cell bladder cancerResponse ratePhase II efficacy studyTis transitional cell carcinomaNanoparticle albumin-bound paclitaxelTransitional cell bladder cancerOngoing phase I trialDose-escalation modelDose-escalation trialEvidence of diseaseGrade 1 toxicityHigh-risk patientsHigh-grade TaInvasive bladder cancerAlbumin-bound paclitaxelTransitional cell carcinoma
2008
565 POSTER Activity of the anti-IGF-IR antibody CP-751,871 in combination with docetaxel as first-line treatment for castration resistant prostate cancer in a randomized Phase II trial
De Bono J, Petrylak D, Calvo E, Saad F, Hudes G, Cooney M, Pollak M, Agus D, Gillessen S, Scranton J. 565 POSTER Activity of the anti-IGF-IR antibody CP-751,871 in combination with docetaxel as first-line treatment for castration resistant prostate cancer in a randomized Phase II trial. European Journal Of Cancer Supplements 2008, 6: 178. DOI: 10.1016/s1359-6349(08)72499-6.Peer-Reviewed Original Research
2005
Phase I/II trial of interferon α2b and ATRA-IV in the treatment of patients with advanced renal cancer
Nanus D, Boorjian S, Milowsky M, Coll D, Cobham M, Kaplan J, Shelton G, Melia J, Petrylak D, Gudas L. Phase I/II trial of interferon α2b and ATRA-IV in the treatment of patients with advanced renal cancer. Journal Of Clinical Oncology 2005, 23: 4606-4606. DOI: 10.1200/jco.2005.23.16_suppl.4606.Peer-Reviewed Original Research
2004
Phase I/II trial of bortezomib plus docetaxel in patients with advanced androgen-independent prostate cancer
Dreicer R, Roth B, Petrylak D, Agus D, Meyers M, Esseltine D, Rodriquez D, Oppedisano P, Wang K, Boral A. Phase I/II trial of bortezomib plus docetaxel in patients with advanced androgen-independent prostate cancer. Journal Of Clinical Oncology 2004, 22: 4654-4654. DOI: 10.1200/jco.2004.22.14_suppl.4654.Peer-Reviewed Original ResearchPhase I/II trial of bortezomib plus docetaxel in patients with advanced androgen-independent prostate cancer
Dreicer R, Roth B, Petrylak D, Agus D, Meyers M, Esseltine D, Rodriquez D, Oppedisano P, Wang K, Boral A. Phase I/II trial of bortezomib plus docetaxel in patients with advanced androgen-independent prostate cancer. Journal Of Clinical Oncology 2004, 22: 4654-4654. DOI: 10.1200/jco.2004.22.90140.4654.Peer-Reviewed Original Research
2002
Chemotherapy for the Treatment of Hormone-Refractory Prostate Cancer
Petrylak D. Chemotherapy for the Treatment of Hormone-Refractory Prostate Cancer. European Urology Open Science 2002, 1: 15-23. DOI: 10.1016/s1569-9056(02)00005-2.Peer-Reviewed Original ResearchHormone-refractory prostate cancerBone painProstate cancerSerum prostate-specific antigen levelProstate-specific antigen levelPhase II trialPhase III trialsSoft tissue metastasesAndrogen ablation therapyEffective palliative therapyAdvanced prostate cancerCombination of mitoxantroneMetastatic prostate cancerTreatment of menHormonal therapyII trialIII trialsOverall survivalPalliative therapyPSA levelsTissue metastasesAntigen levelsTreatment optionsClinical trialsAblation therapy
2000
A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma
Small E, Figlin R, Petrylak D, Vaughn D, Sartor O, Horak I, Pincus R, Kremer A, Bowden C. A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma. Investigational New Drugs 2000, 18: 193-198. PMID: 10857997, DOI: 10.1023/a:1006386115312.Peer-Reviewed Original ResearchConceptsRenal cell carcinomaMetastatic renal cell carcinomaCell carcinomaOpen-label phase II trialCommon drug-related toxicitiesAdvanced renal cell carcinomaPhase II pilot studyNon-hematologic toxicitiesPhase II trialDrug-related toxicityPredictable safety profileReversible myelosuppressionII trialObjective responseSafety profileDisease progressionModerate fatigueWeek 6PatientsSignificant toxicityCarcinomaPilot studyAntitumor potencyWater-soluble analogueCycle 1