Trial · NCT00112736
Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma
NCT00112736, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma. Trials, record NCT00112736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00112736
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma
- NCT number
- NCT00112736
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Pilocytic Astrocytoma, Adult Pineal Gland Astrocytoma, Adult Subependymal Giant Cell Astrocytoma, Recurrent Adult Brain Tumor
- Interventions
- erlotinib, temsirolimus, therapeutic conventional surgery, laboratory biomarker analysis, pharmacological study
- First posted
- 2005-06-03
- Last updated
- 2015-06-15
- Results first posted
- 2015-06-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (Phase I) | based on first 4 weeks of treatment - cycle 1 | Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed. 3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg |
| Primary | Safety/Dose Limiting Toxities Phase I | first 4 weeks of treatment | Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade \>/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy. MTD defined as dose at which fewer than one-third of patients experienced a DLT Outcome measure defines number of participants who had a defined dose limiting toxicity. |
| Primary | Efficacy - Response Phase 1 | at least 8 weeks of treatment | pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan. Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): \>= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer). |
| Primary | Pharmacokinetics (Phase I) | Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration | Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1 Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration |
| Primary | Progression-free Survival at 6 Months (Phase II) | Evaluated at baseline and every other cycle, till Month 6 | Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer). Responses had to be present on 2 consecutive scans and were centrally reviewed. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (Phase I) | based on first 4 weeks of treatment - cycle 1 | Per protocol - | mg | NUMBER |
| PRIMARY | Safety/Dose Limiting Toxities Phase I | first 4 weeks of treatment | participants | NUMBER | |
| PRIMARY | Efficacy - Response Phase 1 | at least 8 weeks of treatment | Response was reviewed only in those patients treated at the MTD (15mg temsirolimus) | participants | NUMBER |
| PRIMARY | Pharmacokinetics (Phase I) | Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration | per protocol | ng/mL | MEAN |
| PRIMARY | Progression-free Survival at 6 Months (Phase II) | Evaluated at baseline and every other cycle, till Month 6 | Primary endpoint PFS6 date of registration; Sample size chosen to discriminate between 15% \& 35% PFS6 rates for GBM patients. With accrual 32 GBM patients, trial would be considered successful if 8 achieved PFS6. This yields 0.92 power to detect a 35% PFS6 rate, with 0.90 probability of rejecting the treatment regimen if the PFS6 rate is only 15%. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (Phase I) | Phase I - Dose Escalation | 15 | mg | ||
| Safety/Dose Limiting Toxities Phase I | Phase 1 - 50mg | 2 | participants | ||
| Safety/Dose Limiting Toxities Phase I | Phase 1 - 25 mg | 3 | participants | ||
| Safety/Dose Limiting Toxities Phase I | Phase 1 - 15mg | 3 | participants | ||
| Efficacy - Response Phase 1 | Phase I 15mg Temsirolimus (MTD Dose) | Complete Response | 0 | participants | |
| Efficacy - Response Phase 1 | Phase I 15mg Temsirolimus (MTD Dose) | Partial response | 1 | participants | |
| Efficacy - Response Phase 1 | Phase I 15mg Temsirolimus (MTD Dose) | Stable | 2 | participants | |
| Efficacy - Response Phase 1 | Phase I 15mg Temsirolimus (MTD Dose) | Progressive Disease | 9 | participants | |
| Pharmacokinetics (Phase I) | Phase 1 - 15mg | 460 | Standard Deviation 219 | ng/mL | |
| Pharmacokinetics (Phase I) | Phase 1 - 25 mg | 428 | Standard Deviation 115 | ng/mL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I (Erlotinib & Temsirolimus) | 22 | |
| Overall Study | STARTED | Phase II (Erlotinib & Temsirolimus) | 47 | |
| Overall Study | COMPLETED | Phase I (Erlotinib & Temsirolimus) | 21 | |
| Overall Study | COMPLETED | Phase II (Erlotinib & Temsirolimus) | 47 | |
| Overall Study | NOT COMPLETED | Phase I (Erlotinib & Temsirolimus) | 1 | |
| Overall Study | NOT COMPLETED | Phase II (Erlotinib & Temsirolimus) | 0 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | White blood Cells | Investigations | Phase I (Erlotinib & Temsirolimus) | 2 | 21 | 2 |
| other | White blood Cells | Investigations | Phase II (Erlotinib & Erlotinib) | 0 | 59 | 0 |
| other | Platelets | Investigations | Phase I (Erlotinib & Temsirolimus) | 4 | 21 | 4 |
| other | Platelets | Investigations | Phase II (Erlotinib & Erlotinib) | 2 | 59 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Phase I (Erlotinib & Temsirolimus) | 2 | 21 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Phase II (Erlotinib & Erlotinib) | 0 | 59 | 0 |
| other | dehydration | Metabolism and nutrition disorders | Phase I (Erlotinib & Temsirolimus) | 3 | 21 | 3 |
| other | dehydration | Metabolism and nutrition disorders | Phase II (Erlotinib & Erlotinib) | 0 | 59 | 0 |
| other | diarrhea | Gastrointestinal disorders | Phase I (Erlotinib & Temsirolimus) | 2 | 21 | 2 |
| other | diarrhea | Gastrointestinal disorders | Phase II (Erlotinib & Erlotinib) | 0 | 59 | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I (Erlotinib & Temsirolimus) | ||
| Total, all-cause mortality | Phase II (Erlotinib & Erlotinib) | ||
| Total, other adverse events | Phase I (Erlotinib & Temsirolimus) | 21 | 21 |
| Total, other adverse events | Phase II (Erlotinib & Erlotinib) | 37 | 59 |
| Total, serious adverse events | Phase I (Erlotinib & Temsirolimus) | 3 | 21 |
| Total, serious adverse events | Phase II (Erlotinib & Erlotinib) | 2 | 59 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24470557 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01CA062399 | NABTC Central Operation Grant (UCSF Project Leader) | PRADOS, MICHAEL D | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 1994 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase I (Erlotinib & Temsirolimus) vs Phase II (Erlotinib & Erlotinib): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00112736
GET https://conductscience.org/api/trials/v1/NCT00112736/events?page=2