Solid TumorsPhase 1NCT00770263
Erlotinib and Temsirolimus for Solid Tumors
A Phase 1 study testing Erlotinib and Temsirolimus in people with Solid Tumors, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Define the maximum tolerated dose and dose limiting side-effects of temsirolimus in combination wtih erlotinib in patients with resistant solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Erlotinib and Temsirolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic Diagnosis: Patients must have a histologically or cytologically proven solid malignancy which is resistant to conventional therapy or for which no effective therapy is known.
- Dose Expansion Phase ONLY: Patients must have archived tumor tissue available (paraffin blocks, unstained tissue sections, tissue cores).
- Tumor Mutational Status (Dose Expansion Phase ONLY): Patients must have tumor harboring PTEN loss, PIK3CA mutation, , and/or EGFR mutation. Patients cannot have KRAS or BRAF mutations. Patients must have mutational status determined by Genomic and Pathology Services at Washington University (GPS@WU) or other CLIA-certified laboratories.
- Dose Expansion Phase ONLY: Patients with squamous carcinoma histology, papillary thyroid carcinoma, and adenoid cystic carcinoma are eligible for the expansion cohort regardless of genetic alterations..
- Measurable or Non-Measurable Disease: 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.
- Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques (PET, CT, MRI, x-ray) or as ≥10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters).
Show all 34Show fewer
- Tumor markers may be considered non-measurable disease.
- A positive bone scan, osteoblastic metastases, and pleural or peritoneal effusions are not considered measurable or non-measurable. Patients with only these lesions are eligible for entry to the study.
- Dose Expansion Phase ONLY: Patients must have a tumor that is easily accessible for biopsy determined by the treating physician or the study PI. Patients must agree to a mandatory biopsy at the end of cycle 1 treatment.
- Recovery from Prior Therapy: Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. No chemotherapy or radiotherapy may be given within 3 weeks prior to the start of protocol treatment. No prior therapy with erlotinib or temsirolimus allowed.
- Age: Patients must be ≥18 years old. Because no dosing or toxicity data are currently available on the use of temsirolimus in combination with erlotinib in patients <18 years of age, children are excluded from this study, but will be eligible for the pediatric phase I single-agent trials, when available.
- Performance Status: ECOG 0-1 at study entry.
- Life Expectancy: Patients must have a life expectancy of greater than 12 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/ALT ≤3.0 x ULN
- alkaline phosphatase ≤2.5 x ULN
- creatinine ≤2.0 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 ≤300 mg/dL (fasting)*
- 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 with triglyceride levels >400 mg/dL can be started on lipid lowering agents and reevaluated within 1 week. If levels go to ≤400 mg/dL, they can be considered for the trial and continue the lipid lowering agents.
- Temsirolimus is primarily metabolized by CYP3A4. 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. A partial list of agents which interact with cytochrome P450 (CYP3A) is found in Appendix AB. Use of agents that potently inhibit CYP3A (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited. Temsirolimus can inhibit CYP2D6, and may decrease metabolism (and increase drug levels) of drugs that are substrates for CYP2D6, such as codeine. The appropriateness of use of such agents is left to physician discretion. A list of drugs that may have potential interactions with CYP2D6 is found in Appendix A. If there is any doubt about eligibility based on concomitant medication, the Principal Investigator, Dr. Andrea Wang-Gillam, should be contacted. All concomitant medications must be recorded.
- Known Allergies: Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin) are not eligible for this trial.
- Sexually Active Patients: 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.
- HIV-Positive Patients: Patients receiving anti-retroviral therapy (HAART) for HIV infection are excluded from the study because of possible pharmacokinetic interactions. Appropriate studies will be undertaken in patients receiving HAART therapy, when indicated.
- Neurologic Status: Patients must not have active CNS disease.
- Recovery from Intercurrent Illness: 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.
- Informed Consent: 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.
- Inclusion of Women and Minorities: Entry to this study is open to both men and women and to all racial and ethnic subgroups.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase I Study of Erlotinib and Temsirolimus in Resistant Solid Malignancies
Define the maximum tolerated dose and dose limiting side-effects of temsirolimus in combination wtih erlotinib in patients with resistant solid tumors
- Conditions
- Solid Tumors
- Being tested
- Erlotinib, Temsirolimus
- Keywords
- any solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva®
TemsirolimusDrug
Also called Torisel™
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1A | Experimental | Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle.
Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles.
Temsirolimus 10 mg IV on days 8, 15, 22, and 29 during the first cycle.
Temsirolimus 10 mg IV on days 8, 15, and 22 during subsequent cycles. Receives: Drug: Erlotinib; Drug: Temsirolimus |
| Dose Level 1 | Experimental | Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle.
Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles.
Temsirolimus 15 mg IV on days 8, 15, 22, and 29 during the first cycle.
Temsirolimus 15 mg IV on days 8, 15, and 22 during subsequent cycles. Receives: Drug: Erlotinib; Drug: Temsirolimus |
| Dose Level 2 | Experimental | Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle.
Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles.
Temsirolimus 20 mg IV on days 8, 15, 22, and 29 during the first cycle.
Temsirolimus 20 mg IV on days 8, 15, and 22 during subsequent cycles. Receives: Drug: Erlotinib; Drug: Temsirolimus |
| Dose Level 3 | Experimental | Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle.
Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles.
Temsirolimus 25 mg IV on days 8, 15, 22, and 29 during the first cycle.
Temsirolimus 25 mg IV on days 8, 15, and 22 during subsequent cycles. Receives: Drug: Erlotinib; Drug: Temsirolimus |
| Dose Expansion Phase | Experimental | Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle.
Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles.
Temsirolimus 25 mg IV on days 8, 15, 22, and 29 during the first cycle.
Temsirolimus 25 mg IV on days 8, 15, and 22 during subsequent cycles. Receives: Drug: Erlotinib; Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the maximum tolerated dose and dose-limiting toxicities of temsirolimus in combination with erlotinib in patients with resistant solid malignancies.
Measured: 3 years for MTD to be determined, DLT occurs in 1st cycle only
To determine the incidence and severity of other toxicities of temsirolimus in combination with erlotinib in patients with resistant solid malignancies.
Measured: 30 days after end of treatment
Secondary outcomes (3)
To assess the pharmacodynamic profile of temsirolimus in combination with erlotinib.
Measured: Prior to each cycle
To determine any anti-tumor activity and response to the combination of temsirolimus and erlotinib in treatment of patients with resistant solid malignancies.
Measured: End of treatment
To evaluate the relation between pS6K1 and p-Akt to clinical response to temsirolimus.
Measured: End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startMay 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Andrea Wang-Gillam, M.D., Ph.D., Principal investigator, Washington Univerisity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770263
- Sponsor's protocol ID
- 08-1092 / 201108327
- Status last verified
- Dec 2014
- First submitted
- 8 Oct 2008
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vignot S, Faivre S, Aguirre D, Raymond E. mTOR-targeted therapy of cancer with rapamycin derivatives. Ann Oncol. 2005 Apr;16(4):525-37. doi: 10.1093/annonc/mdi113. Epub 2005 Feb 22.
PubMed 15728109Sabers CJ, Martin MM, Brunn GJ, Williams JM, Dumont FJ, Wiederrecht G, Abraham RT. Isolation of a protein target of the FKBP12-rapamycin complex in mammalian cells. J Biol Chem. 1995 Jan 13;270(2):815-22. doi: 10.1074/jbc.270.2.815.
PubMed 7822316Lorenz MC, Heitman J. TOR mutations confer rapamycin resistance by preventing interaction with FKBP12-rapamycin. J Biol Chem. 1995 Nov 17;270(46):27531-7. doi: 10.1074/jbc.270.46.27531.
PubMed 7499212Janus A, Robak T, Smolewski P. The mammalian target of the rapamycin (mTOR) kinase pathway: its role in tumourigenesis and targeted antitumour therapy. Cell Mol Biol Lett. 2005;10(3):479-98.
PubMed 16217558O'Reilly KE, Rojo F, She QB, Solit D, Mills GB, Smith D, Lane H, Hofmann F, Hicklin DJ, Ludwig DL, Baselga J, Rosen N. mTOR inhibition induces upstream receptor tyrosine kinase signaling and activates Akt. Cancer Res. 2006 Feb 1;66(3):1500-8. doi: 10.1158/0008-5472.CAN-05-2925.
PubMed 16452206Oldham S, Hafen E. Insulin/IGF and target of rapamycin signaling: a TOR de force in growth control. Trends Cell Biol. 2003 Feb;13(2):79-85. doi: 10.1016/s0962-8924(02)00042-9.
PubMed 12559758Bianco R, Melisi D, Ciardiello F, Tortora G. Key cancer cell signal transduction pathways as therapeutic targets. Eur J Cancer. 2006 Feb;42(3):290-4. doi: 10.1016/j.ejca.2005.07.034. Epub 2006 Jan 11.
PubMed 16376541Sansal I, Sellers WR. The biology and clinical relevance of the PTEN tumor suppressor pathway. J Clin Oncol. 2004 Jul 15;22(14):2954-63. doi: 10.1200/JCO.2004.02.141.
PubMed 15254063DeGraffenried LA, Fulcher L, Friedrichs WE, Grunwald V, Ray RB, Hidalgo M. Reduced PTEN expression in breast cancer cells confers susceptibility to inhibitors of the PI3 kinase/Akt pathway. Ann Oncol. 2004 Oct;15(10):1510-6. doi: 10.1093/annonc/mdh388.
PubMed 15367412Manning BD, Tee AR, Logsdon MN, Blenis J, Cantley LC. Identification of the tuberous sclerosis complex-2 tumor suppressor gene product tuberin as a target of the phosphoinositide 3-kinase/akt pathway. Mol Cell. 2002 Jul;10(1):151-62. doi: 10.1016/s1097-2765(02)00568-3.
PubMed 12150915Hidalgo M, Rowinsky EK. The rapamycin-sensitive signal transduction pathway as a target for cancer therapy. Oncogene. 2000 Dec 27;19(56):6680-6. doi: 10.1038/sj.onc.1204091.
PubMed 11426655Rowinsky EK. Targeting the molecular target of rapamycin (mTOR). Curr Opin Oncol. 2004 Nov;16(6):564-75. doi: 10.1097/01.cco.0000143964.74936.d1.
PubMed 15627018Blagosklonny MV, Darzynkiewicz Z. Four birds with one stone: RAPA as potential anticancer therapy. Cancer Biol Ther. 2002 Jul-Aug;1(4):359-61. No abstract available.
PubMed 12432246Gambacorti-Passerini CB, Gunby RH, Piazza R, Galietta A, Rostagno R, Scapozza L. Molecular mechanisms of resistance to imatinib in Philadelphia-chromosome-positive leukaemias. Lancet Oncol. 2003 Feb;4(2):75-85. doi: 10.1016/s1470-2045(03)00979-3.
PubMed 12573349Dudkin L, Dilling MB, Cheshire PJ, Harwood FC, Hollingshead M, Arbuck SG, Travis R, Sausville EA, Houghton PJ. Biochemical correlates of mTOR inhibition by the rapamycin ester CCI-779 and tumor growth inhibition. Clin Cancer Res. 2001 Jun;7(6):1758-64.
PubMed 11410517
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Erlotinib and Temsirolimus in Resistant Solid Malignancies
- ClinicalTrials.gov ID
- NCT00770263
- Acronym / sponsor ID
- 08-1092 / 201108327
- Conditions
- Solid Tumors
- Keywords
- any solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Define the maximum tolerated dose and dose limiting side-effects of temsirolimus in combination wtih erlotinib in patients with resistant solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1A | Experimental | Drug: Erlotinib, Drug: TemsirolimusErlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 10 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 10 mg IV on days 8, 15, and 22 during subsequent cycles. |
| Dose Level 1 | Experimental | Drug: Erlotinib, Drug: TemsirolimusErlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 15 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 15 mg IV on days 8, 15, and 22 during subsequent cycles. |
| Dose Level 2 | Experimental | Drug: Erlotinib, Drug: TemsirolimusErlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 20 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 20 mg IV on days 8, 15, and 22 during subsequent cycles. |
| Dose Level 3 | Experimental | Drug: Erlotinib, Drug: TemsirolimusErlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 25 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 25 mg IV on days 8, 15, and 22 during subsequent cycles. |
| Dose Expansion Phase | Experimental | Drug: Erlotinib, Drug: TemsirolimusErlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 25 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 25 mg IV on days 8, 15, and 22 during subsequent cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Histologic Diagnosis: Patients must have a histologically or cytologically proven solid malignancy which is resistant to conventional therapy or for which no effective therapy is known.
- Dose Expansion Phase ONLY: Patients must have archived tumor tissue available (paraffin blocks, unstained tissue sections, tissue cores).
- Tumor Mutational Status (Dose Expansion Phase ONLY): Patients must have tumor harboring PTEN loss, PIK3CA mutation, , and/or EGFR mutation. Patients cannot have KRAS or BRAF mutations. Patients must have mutational status determined by Genomic and Pathology Services at Washington University (GPS@WU) or other CLIA-certified laboratories.
- Dose Expansion Phase ONLY: Patients with squamous carcinoma histology, papillary thyroid carcinoma, and adenoid cystic carcinoma are eligible for the expansion cohort regardless of genetic alterations..
- Measurable or Non-Measurable Disease: 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibAlso: Tarceva® | Drug | Dose Expansion Phase, Dose Level 1, Dose Level 1A, Dose Level 2, Dose Level 3 |
| TemsirolimusAlso: Torisel™ | Drug | Dose Expansion Phase, Dose Level 1, Dose Level 1A, Dose Level 2, Dose Level 3 |
Primary outcome
To define the maximum tolerated dose and dose-limiting toxicities of temsirolimus in combination with erlotinib in patients with resistant solid malignancies.
Time frame: 3 years for MTD to be determined, DLT occurs in 1st cycle only
To determine the incidence and severity of other toxicities of temsirolimus in combination with erlotinib in patients with resistant solid malignancies.
Time frame: 30 days after end of treatment
3 secondary outcomes
To assess the pharmacodynamic profile of temsirolimus in combination with erlotinib.
Time frame: Prior to each cycle
To determine any anti-tumor activity and response to the combination of temsirolimus and erlotinib in treatment of patients with resistant solid malignancies.
Time frame: End of treatment
To evaluate the relation between pS6K1 and p-Akt to clinical response to temsirolimus.
Time frame: End of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 15728109Vignot S, Faivre S, Aguirre D, Raymond E. mTOR-targeted therapy of cancer with rapamycin derivatives. Ann Oncol. 2005 Apr;16(4):525-37. doi: 10.1093/annonc/mdi113. Epub 2005 Feb 22.
- Background: PubMed 7822316Sabers CJ, Martin MM, Brunn GJ, Williams JM, Dumont FJ, Wiederrecht G, Abraham RT. Isolation of a protein target of the FKBP12-rapamycin complex in mammalian cells. J Biol Chem. 1995 Jan 13;270(2):815-22. doi: 10.1074/jbc.270.2.815.
- Background: PubMed 7499212Lorenz MC, Heitman J. TOR mutations confer rapamycin resistance by preventing interaction with FKBP12-rapamycin. J Biol Chem. 1995 Nov 17;270(46):27531-7. doi: 10.1074/jbc.270.46.27531.
- Background: PubMed 16217558Janus A, Robak T, Smolewski P. The mammalian target of the rapamycin (mTOR) kinase pathway: its role in tumourigenesis and targeted antitumour therapy. Cell Mol Biol Lett. 2005;10(3):479-98.
- Background: PubMed 16452206O'Reilly KE, Rojo F, She QB, Solit D, Mills GB, Smith D, Lane H, Hofmann F, Hicklin DJ, Ludwig DL, Baselga J, Rosen N. mTOR inhibition induces upstream receptor tyrosine kinase signaling and activates Akt. Cancer Res. 2006 Feb 1;66(3):1500-8. doi: 10.1158/0008-5472.CAN-05-2925.
- Background: PubMed 12559758Oldham S, Hafen E. Insulin/IGF and target of rapamycin signaling: a TOR de force in growth control. Trends Cell Biol. 2003 Feb;13(2):79-85. doi: 10.1016/s0962-8924(02)00042-9.
- Background: PubMed 16376541Bianco R, Melisi D, Ciardiello F, Tortora G. Key cancer cell signal transduction pathways as therapeutic targets. Eur J Cancer. 2006 Feb;42(3):290-4. doi: 10.1016/j.ejca.2005.07.034. Epub 2006 Jan 11.
- Background: PubMed 15254063Sansal I, Sellers WR. The biology and clinical relevance of the PTEN tumor suppressor pathway. J Clin Oncol. 2004 Jul 15;22(14):2954-63. doi: 10.1200/JCO.2004.02.141.
- Background: PubMed 15367412DeGraffenried LA, Fulcher L, Friedrichs WE, Grunwald V, Ray RB, Hidalgo M. Reduced PTEN expression in breast cancer cells confers susceptibility to inhibitors of the PI3 kinase/Akt pathway. Ann Oncol. 2004 Oct;15(10):1510-6. doi: 10.1093/annonc/mdh388.
- Background: PubMed 12150915Manning BD, Tee AR, Logsdon MN, Blenis J, Cantley LC. Identification of the tuberous sclerosis complex-2 tumor suppressor gene product tuberin as a target of the phosphoinositide 3-kinase/akt pathway. Mol Cell. 2002 Jul;10(1):151-62. doi: 10.1016/s1097-2765(02)00568-3.
- Background: PubMed 11426655Hidalgo M, Rowinsky EK. The rapamycin-sensitive signal transduction pathway as a target for cancer therapy. Oncogene. 2000 Dec 27;19(56):6680-6. doi: 10.1038/sj.onc.1204091.
- Background: PubMed 15627018Rowinsky EK. Targeting the molecular target of rapamycin (mTOR). Curr Opin Oncol. 2004 Nov;16(6):564-75. doi: 10.1097/01.cco.0000143964.74936.d1.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Wang-Gillam, M.D., Ph.D. principal investigator
Washington Univerisity School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erlotinib and Temsirolimus in people with Solid Tumors, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the maximum tolerated dose and dose-limiting toxicities of temsirolimus in combination with erlotinib in patients with resistant solid malignancies. (time frame: 3 years for MTD to be determined, DLT occurs in 1st cycle only). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770263, which also lists 68 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.