Phase I Study of Docetaxel and Temsirolimus in Resistant Solid Malignancies
NCT ID: NCT00703625
Last Updated: 2017-03-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
26 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-03-08
Study Completion Date
2011-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Rationale:
The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of 289 kDa; kinases have been shown to be important regulators of cancer cell cycle, proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the signaling of malignant cell growth, proliferation, differentiation, migration, and survival. Inhibition of mTOR would result in arrest of cell growth in the G1 phase of the cell cycle.
Temsirolimus (CCI-779) is a soluble ester analogue of rapamycin (sirolimus) which has shown impressive in vitro and in vivo cytostatic activity in selectively inhibiting mTOR. In animal models, temsirolimus has demonstrated an impressive cytostatic effect on a wide variety of cancer cells. In vitro, it inhibited the growth of human T-cell leukemia, glioblastoma, melanoma, prostate, breast, renal cell, and pancreatic cells, all of which showed particular sensitivity to temsirolimus, with significant growth inhibition at concentrations of less that 0.01micrometers. In Phase I trials, temsirolimus has been investigated as a single agent on a weekly schedule as well as daily for 5 days every other week, and evidence of activity was observed over the entire dose range (15 - 220 mg/m2) in patients with both breast and renal cancer. There was no apparent relationship between exposure and clinical benefit, suggesting that the inhibition of mTOR may be achieved at doses well below dose levels that result in dose limiting toxicities. Major tumor responses were noted in Phase I trials in patients previously treated with lung, breast, renal as well as neuroendocrine tumors. Minor responses were noted in soft tissue sarcoma, endometrial, and cervical carcinoma.
Docetaxel is a taxane analog which is active against many solid tumors including breast, non-small cell lung, prostate, gastric, ovarian, head and neck, and pancreatic cancers, soft tissue sarcoma, and melanoma. It has been shown in several Phase III studies to have clinically significant activity in several solid tumors.
We propose treating patients with resistant solid malignancies with docetaxel and temsirolimus. In a study using human breast cancer cell lines, mTOR inhibition with rapamycin had a synergistic cytotoxic effect with paclitaxel. Given the novel mechanism of action of mTOR inhibitors and known synergistic activity of an mTOR inhibitor, rapamycin, with a taxane, paclitaxel, in vitro, we envision that this regimen would be highly active in patients with solid tumor malignancies.
Objectives:
Primary
* To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of temsirolimus in combination with pegylated liposomal doxorubicin in patients with resistant solid malignancies.
* To determine the incidence and severity of other toxicities of temsirolimus in combination with pegylated liposomal doxorubicin in patients with resistant solid malignancies.
Secondary
* To assess the pharmacokinetic profile of temsirolimus in combination with pegylated liposomal doxorubicin.
* To determine any anti-tumor activity and response to the combination of temsirolimus and pegylated liposomal doxorubicin in treatment of patients with resistant solid malignancies.
The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of 289 kDa; kinases have been shown to be important regulators of cancer cell cycle, proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the signaling of malignant cell growth, proliferation, differentiation, migration, and survival. Inhibition of mTOR would result in arrest of cell growth in the G1 phase of the cell cycle.
Temsirolimus (CCI-779) is a soluble ester analogue of rapamycin (sirolimus) which has shown impressive in vitro and in vivo cytostatic activity in selectively inhibiting mTOR. In animal models, temsirolimus has demonstrated an impressive cytostatic effect on a wide variety of cancer cells. In vitro, it inhibited the growth of human T-cell leukemia, glioblastoma, melanoma, prostate, breast, renal cell, and pancreatic cells, all of which showed particular sensitivity to temsirolimus, with significant growth inhibition at concentrations of less that 0.01micrometers. In Phase I trials, temsirolimus has been investigated as a single agent on a weekly schedule as well as daily for 5 days every other week, and evidence of activity was observed over the entire dose range (15 - 220 mg/m2) in patients with both breast and renal cancer. There was no apparent relationship between exposure and clinical benefit, suggesting that the inhibition of mTOR may be achieved at doses well below dose levels that result in dose limiting toxicities. Major tumor responses were noted in Phase I trials in patients previously treated with lung, breast, renal as well as neuroendocrine tumors. Minor responses were noted in soft tissue sarcoma, endometrial, and cervical carcinoma.
Docetaxel is a taxane analog which is active against many solid tumors including breast, non-small cell lung, prostate, gastric, ovarian, head and neck, and pancreatic cancers, soft tissue sarcoma, and melanoma. It has been shown in several Phase III studies to have clinically significant activity in several solid tumors.
We propose treating patients with resistant solid malignancies with docetaxel and temsirolimus. In a study using human breast cancer cell lines, mTOR inhibition with rapamycin had a synergistic cytotoxic effect with paclitaxel. Given the novel mechanism of action of mTOR inhibitors and known synergistic activity of an mTOR inhibitor, rapamycin, with a taxane, paclitaxel, in vitro, we envision that this regimen would be highly active in patients with solid tumor malignancies.
Objectives:
Primary
* To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of temsirolimus in combination with pegylated liposomal doxorubicin in patients with resistant solid malignancies.
* To determine the incidence and severity of other toxicities of temsirolimus in combination with pegylated liposomal doxorubicin in patients with resistant solid malignancies.
Secondary
* To assess the pharmacokinetic profile of temsirolimus in combination with pegylated liposomal doxorubicin.
* To determine any anti-tumor activity and response to the combination of temsirolimus and pegylated liposomal doxorubicin in treatment of patients with resistant solid malignancies.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase I Study of DOXIL and Temsirolimus in Resistant Solid Malignancies
NCT00703170
Resistant Solid Malignancies
COMPLETED
PHASE1
Erlotinib and Temsirolimus for Solid Tumors
NCT00770263
Solid Tumors
COMPLETED
PHASE1
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor
NCT04648254
Solid Tumor
Advanced Cancer
Metastatic Cancer
COMPLETED
PHASE1
Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (Taxotere®) for Subjects With Advanced Cancer Tumors
NCT00511576
Breast Cancer
Lung Cancer
Pulmonary Cancer
+5 more
TERMINATED
PHASE1
Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors
NCT01251562
Solid Tumors
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Resistant Solid Malignancies
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Temsirolimus IV 15 mg weekly
Docetaxel 60 mg/m2 IV once every three weeks.
Group Type
EXPERIMENTAL
Temsirolimus
Intervention Type
DRUG
Docetaxel
Intervention Type
DRUG
Cohort 2
Temsirolimus IV 25 mg weekly
Docetaxel IV 60 mg/m2 once every 3 weeks
Group Type
EXPERIMENTAL
Temsirolimus
Intervention Type
DRUG
Docetaxel
Intervention Type
DRUG
Cohort 1A
Temsirolimus IV 15 mg weekly
Docetaxel IV 50 mg/m2 every 3 weeks.
Group Type
EXPERIMENTAL
Temsirolimus
Intervention Type
DRUG
Docetaxel
Intervention Type
DRUG
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Temsirolimus
Intervention Type
DRUG
Docetaxel
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Torisel
CCI-779
Taxotere
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* Patients must have a histologically or cytologically proven solid malignancy which is resistant to conventional therapy or for which no effective therapy is known.
* Patients with measurable or non-measurable disease are eligible for entry to this study. In addition, patients without measurable or non-measurable disease are also eligible.
* Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Neuropathy must have recovered to grade 1. No chemotherapy or radiotherapy may be given within 4 weeks prior to the start of protocol treatment.
* Patients must be ≥18 years old.
* ECOG 0-2 at study entry.
* Patients must have a life expectancy of greater than 8 weeks.
* Required Laboratory Values:
* absolute neutrophil count ≥1,500/mm3
* platelets ≥100,000/mm3
* hemoglobin ≥9.0 g/dL
* total bilirubin ≤1.5 x ULN
* AST(SGOT)/ALT(SGPT) ≤1.5 x ULN (≤2.5 x ULN for patients with liver metastases
* alkaline phosphatase ≤2.5 x ULN
* creatinine ≤1.5 x ULN OR
* creatinine clearance ≥60 mL/min/1.732 for patients with creatinine levels above 2.0 mg/dl
* serum cholesterol ≤350 mg/dL /9.0 mmol/L (fasting)
* triglycerides ≤400 mg/dL (fasting)\*
* albumin ≥3.0 mg/dL
* PT/INR ≤1.5, unless the patient is on full dose warfarin or stable dose of LMW heparin with a therapeutic INR of \>1.5 - ≤3
* Patients cannot be receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels.
* Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin) are not eligible for this trial.
* For all sexually active patients, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation. Non-pregnant status will be determined in all women of childbearing potential. Pregnant and nursing women are not eligible.
* Patients must not have active CNS disease.
* Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
* Patients must have signed a Washington University, Human Research Protection Office (HRPO) approved informed consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
* Patients with measurable or non-measurable disease are eligible for entry to this study. In addition, patients without measurable or non-measurable disease are also eligible.
* Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Neuropathy must have recovered to grade 1. No chemotherapy or radiotherapy may be given within 4 weeks prior to the start of protocol treatment.
* Patients must be ≥18 years old.
* ECOG 0-2 at study entry.
* Patients must have a life expectancy of greater than 8 weeks.
* Required Laboratory Values:
* absolute neutrophil count ≥1,500/mm3
* platelets ≥100,000/mm3
* hemoglobin ≥9.0 g/dL
* total bilirubin ≤1.5 x ULN
* AST(SGOT)/ALT(SGPT) ≤1.5 x ULN (≤2.5 x ULN for patients with liver metastases
* alkaline phosphatase ≤2.5 x ULN
* creatinine ≤1.5 x ULN OR
* creatinine clearance ≥60 mL/min/1.732 for patients with creatinine levels above 2.0 mg/dl
* serum cholesterol ≤350 mg/dL /9.0 mmol/L (fasting)
* triglycerides ≤400 mg/dL (fasting)\*
* albumin ≥3.0 mg/dL
* PT/INR ≤1.5, unless the patient is on full dose warfarin or stable dose of LMW heparin with a therapeutic INR of \>1.5 - ≤3
* Patients cannot be receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels.
* Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin) are not eligible for this trial.
* For all sexually active patients, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation. Non-pregnant status will be determined in all women of childbearing potential. Pregnant and nursing women are not eligible.
* Patients must not have active CNS disease.
* Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
* Patients must have signed a Washington University, Human Research Protection Office (HRPO) approved informed consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joel Picus, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Wullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism. Cell. 2006 Feb 10;124(3):471-84. doi: 10.1016/j.cell.2006.01.016.
Reference Type
BACKGROUND
Adjei AA, Hidalgo M. Intracellular signal transduction pathway proteins as targets for cancer therapy. J Clin Oncol. 2005 Aug 10;23(23):5386-403. doi: 10.1200/JCO.2005.23.648. Epub 2005 Jun 27.
Reference Type
BACKGROUND
Smolewski P. Recent developments in targeting the mammalian target of rapamycin (mTOR) kinase pathway. Anticancer Drugs. 2006 Jun;17(5):487-94. doi: 10.1097/00001813-200606000-00001.
Reference Type
BACKGROUND
Thomas GV. mTOR and cancer: reason for dancing at the crossroads? Curr Opin Genet Dev. 2006 Feb;16(1):78-84. doi: 10.1016/j.gde.2005.12.003. Epub 2005 Dec 15.
Reference Type
BACKGROUND
Elit L. CCI-779 Wyeth. Curr Opin Investig Drugs. 2002 Aug;3(8):1249-53.
Reference Type
BACKGROUND
Huang S, Houghton PJ. Targeting mTOR signaling for cancer therapy. Curr Opin Pharmacol. 2003 Aug;3(4):371-7. doi: 10.1016/s1471-4892(03)00071-7.
Reference Type
BACKGROUND
Sawyers CL. Will mTOR inhibitors make it as cancer drugs? Cancer Cell. 2003 Nov;4(5):343-8. doi: 10.1016/s1535-6108(03)00275-7. No abstract available.
Reference Type
BACKGROUND
Del Bufalo D, Ciuffreda L, Trisciuoglio D, Desideri M, Cognetti F, Zupi G, Milella M. Antiangiogenic potential of the Mammalian target of rapamycin inhibitor temsirolimus. Cancer Res. 2006 Jun 1;66(11):5549-54. doi: 10.1158/0008-5472.CAN-05-2825.
Reference Type
BACKGROUND
Chan S. Targeting the mammalian target of rapamycin (mTOR): a new approach to treating cancer. Br J Cancer. 2004 Oct 18;91(8):1420-4. doi: 10.1038/sj.bjc.6602162.
Reference Type
BACKGROUND
Teachey DT, Obzut DA, Cooperman J, Fang J, Carroll M, Choi JK, Houghton PJ, Brown VI, Grupp SA. The mTOR inhibitor CCI-779 induces apoptosis and inhibits growth in preclinical models of primary adult human ALL. Blood. 2006 Feb 1;107(3):1149-55. doi: 10.1182/blood-2005-05-1935. Epub 2005 Sep 29.
Reference Type
BACKGROUND
Hidalgo M, Rowinsky E, Erlichmann C, et al. A Phase I and Pharmacological Study of CCI-779, a Rapamycin Ester Cell Cycle Inhibitor. Annals of Oncology 11(Suppl4): 133, 2000.
Reference Type
BACKGROUND
Raymond E, Alexandre J, Faivre S, Vera K, Materman E, Boni J, Leister C, Korth-Bradley J, Hanauske A, Armand JP. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol. 2004 Jun 15;22(12):2336-47. doi: 10.1200/JCO.2004.08.116. Epub 2004 May 10.
Reference Type
BACKGROUND
Punt CJ, Boni J, Bruntsch U, Peters M, Thielert C. Phase I and pharmacokinetic study of CCI-779, a novel cytostatic cell-cycle inhibitor, in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors. Ann Oncol. 2003 Jun;14(6):931-7. doi: 10.1093/annonc/mdg248.
Reference Type
BACKGROUND
Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 Aug 10;23(23):5347-56. doi: 10.1200/JCO.2005.13.466. Epub 2005 Jun 27.
Reference Type
BACKGROUND
Oza A, Elit L, Biagi J, Gotlieb W, Tonkin K, Tsao MN, et al. A Phase II Study of Temsirolimus (CCI-779) in Patients with Metastatic and/or Recurrent Endometrial Cancer. Clinical Cancer Research 11: 9099s, 2005
Reference Type
BACKGROUND
Chan S, Scheulen ME, Johnston S, Mross K, Cardoso F, Dittrich C, Eiermann W, Hess D, Morant R, Semiglazov V, Borner M, Salzberg M, Ostapenko V, Illiger HJ, Behringer D, Bardy-Bouxin N, Boni J, Kong S, Cincotta M, Moore L. Phase II study of temsirolimus (CCI-779), a novel inhibitor of mTOR, in heavily pretreated patients with locally advanced or metastatic breast cancer. J Clin Oncol. 2005 Aug 10;23(23):5314-22. doi: 10.1200/JCO.2005.66.130. Epub 2005 Jun 13.
Reference Type
BACKGROUND
Atkins MB, Hidalgo M, Stadler WM, Logan TF, Dutcher JP, Hudes GR, Park Y, Liou SH, Marshall B, Boni JP, Dukart G, Sherman ML. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol. 2004 Mar 1;22(5):909-18. doi: 10.1200/JCO.2004.08.185.
Reference Type
BACKGROUND
Pandya KJ, Levy DE, Hidalgo M, et al. A Randomized, Phase II ECOG Trial of Two Dose Levels of Temsirolimus (CCI-779) in Patients with Extensive Stage Small Cell Lung Cancer in Remission After Induction Chemotherapy. A Preliminary Report. Journal of Clinical Oncology. ASCO Annual Meeting Proceedings; 23: 7005, 2005.
Reference Type
BACKGROUND
Margolin K, Longmate J, Baratta T, Synold T, Christensen S, Weber J, Gajewski T, Quirt I, Doroshow JH. CCI-779 in metastatic melanoma: a phase II trial of the California Cancer Consortium. Cancer. 2005 Sep 1;104(5):1045-8. doi: 10.1002/cncr.21265.
Reference Type
BACKGROUND
Chang SM, Wen P, Cloughesy T, Greenberg H, Schiff D, Conrad C, Fink K, Robins HI, De Angelis L, Raizer J, Hess K, Aldape K, Lamborn KR, Kuhn J, Dancey J, Prados MD; North American Brain Tumor Consortium and the National Cancer Institute. Phase II study of CCI-779 in patients with recurrent glioblastoma multiforme. Invest New Drugs. 2005 Aug;23(4):357-61. doi: 10.1007/s10637-005-1444-0.
Reference Type
BACKGROUND
Hudes G, Carducci M, Tomczak P, et al. A Phase 3, Randomized, 3-arm Study of Temsirolimus (TEMSR) or Interferon-alpha (IFN) or the Combination of TEMSR + IFN in the Treatment of First-Line, Poor-Risk Patients with Advanced Renal Cell Carcinoma (adv RCC). Journal of Clinical Oncology, ASCO Annual Meeting Proceedings; 24: LBA4, 2006.
Reference Type
BACKGROUND
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
Reference Type
BACKGROUND
Ramaswamy B, Puhalla S. Docetaxel: a tubulin-stabilizing agent approved for the management of several solid tumors. Drugs Today (Barc). 2006 Apr;42(4):265-79. doi: 10.1358/dot.2006.42.4.968648.
Reference Type
BACKGROUND
Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F, Hammershaimb L. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol. 2000 Jun;18(12):2354-62. doi: 10.1200/JCO.2000.18.12.2354.
Reference Type
BACKGROUND
Jones SE, Erban J, Overmoyer B, Budd GT, Hutchins L, Lower E, Laufman L, Sundaram S, Urba WJ, Pritchard KI, Mennel R, Richards D, Olsen S, Meyers ML, Ravdin PM. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol. 2005 Aug 20;23(24):5542-51. doi: 10.1200/JCO.2005.02.027.
Reference Type
BACKGROUND
Charles KA, Rivory LP, Stockler MR, Beale P, Beith J, Boyer M, Clarke SJ. Predicting the toxicity of weekly docetaxel in advanced cancer. Clin Pharmacokinet. 2006;45(6):611-22. doi: 10.2165/00003088-200645060-00004.
Reference Type
BACKGROUND
Chen YM, Shih JF, Perng RP, Tsai CM, Whang-Peng J. A randomized trial of different docetaxel schedules in non-small cell lung cancer patients who failed previous platinum-based chemotherapy. Chest. 2006 Apr;129(4):1031-8. doi: 10.1378/chest.129.4.1031.
Reference Type
BACKGROUND
Schuette W, Nagel S, Blankenburg T, Lautenschlaeger C, Hans K, Schmidt EW, Dittrich I, Schweisfurth H, von Weikersthal LF, Raghavachar A, Reissig A, Serke M. Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel. J Clin Oncol. 2005 Nov 20;23(33):8389-95. doi: 10.1200/JCO.2005.02.3739.
Reference Type
BACKGROUND
Ford HE, Yap YS, Miles DW, Makris A, Hall M, Miller L, Harries M, Smith IE, Johnston SR. A phase II study of weekly docetaxel in patients with anthracycline pretreated metastatic breast cancer. Cancer Chemother Pharmacol. 2006 Dec;58(6):809-15. doi: 10.1007/s00280-006-0222-9. Epub 2006 Mar 10.
Reference Type
BACKGROUND
Mondesire WH, Jian W, Zhang H, Ensor J, Hung MC, Mills GB, Meric-Bernstam F. Targeting mammalian target of rapamycin synergistically enhances chemotherapy-induced cytotoxicity in breast cancer cells. Clin Cancer Res. 2004 Oct 15;10(20):7031-42. doi: 10.1158/1078-0432.CCR-04-0361.
Reference Type
BACKGROUND
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
Reference Type
BACKGROUND
Yazbeck VY, Georgakis GV, Li Y, and Younes A. The mTOR Inhibitor CCI-779 (Temsirolimus) Downregulates p21 and Induces Cell Cycle Arrest and Autophagy in Mantle Cell Lymphoma (MCL). Journal of Clinical Oncology, ASCO Annual Meeting Proceedings; 24:7573, 2006.
Reference Type
BACKGROUND
Duran I, Siu LL, Oza AM, Chung TB, Sturgeon J, Townsley CA, Pond GR, Seymour L, Niroumand M. Characterisation of the lung toxicity of the cell cycle inhibitor temsirolimus. Eur J Cancer. 2006 Aug;42(12):1875-80. doi: 10.1016/j.ejca.2006.03.015. Epub 2006 Jun 27.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.siteman.wustl.edu
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
07-0444
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
TTP607 in Refractory Solid Malignancies
NCT00939172
WITHDRAWN
PHASE1
A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
NCT00277043
COMPLETED
PHASE3
PI3K Inhibitor BKM120 and Docetaxel in Treating Patients With Advanced Solid Tumor That is Locally Advanced, Cannot Be Removed By Surgery, or Metastatic
NCT01540253
COMPLETED
PHASE1
Treatment With MK6592 and an Anti-cancer Drug in Patients With Advanced Solid Tumors (6592-001)
NCT00359671
TERMINATED
PHASE1
Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
NCT00016185
COMPLETED
PHASE1
Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors
NCT00080041
COMPLETED
PHASE1
Phase I Study of TAS-106 in Combo With Carboplatin
NCT00752011
COMPLETED
PHASE1
Combination Paclitaxel, Carboplatin and Temozolomide
NCT00249964
COMPLETED
PHASE1
Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors
NCT05653661
WITHDRAWN
PHASE1
A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors
NCT01567163
COMPLETED
PHASE2
Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors
NCT03780517
COMPLETED
PHASE1
Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer
NCT01019941
COMPLETED
PHASE1
SB-715992 In Combination With Docetaxel In Patients With Solid Tumors
NCT00169520
COMPLETED
PHASE1
Phase 1, Multiple Dose Study of MPC-6827 in Subjects With Refractory Solid Tumors
NCT00394446
COMPLETED
PHASE1
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
NCT06120075
ACTIVE_NOT_RECRUITING
PHASE1
A Study of AMG 193 in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
NCT05094336
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
A Study of APG-1252 in Patients With SCLC or Other Solid Tumors
NCT03080311
COMPLETED
PHASE1
A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
NCT00001383
COMPLETED
PHASE1
Pharmacokinetics Study of Liposomal Paclitaxel in Humans
NCT00606515
COMPLETED
PHASE4
A Study of CriPec® Docetaxel Given to Patients With Solid Tumours
NCT02442531
COMPLETED
PHASE1
A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
NCT06244485
RECRUITING
PHASE1
Pharmacokinetic Study of Docetaxel-PNP and Taxotere to Treat Patient With Advanced Solid Cancer
NCT02274610
COMPLETED
PHASE1
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
NCT03838926
RECRUITING
PHASE1
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
NCT01140607
COMPLETED
PHASE1
A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer
NCT05076552
ACTIVE_NOT_RECRUITING
PHASE1