A Phase 2 interventional study of Erlotinib and Temsirolimus in Squamous Cell Carcinoma, sponsored by New Mexico Cancer Research Alliance. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-10.
Sponsored by New Mexico Cancer Research Alliance · Phase 2, Interventional, and Treatment
The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with preclinical xenograft data. Patients will be treated with the combination of temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The primary signal of efficacy will be progression free survival (PFS), anticipating that PFS will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or cetuximab monotherapy.
This is a phase II, multicenter, single arm, open-label study. Thirty-seven patients with advanced, platinum-refractory or platinum-ineligible squamous cell carcinoma of the head and neck will be sequentially enrolled to a single treatment arm. Patients will be treated with continuous, 28-day cycles of 150 mg of erlotinib by mouth daily and 15 mg of temsirolimus intervenously weekly. In the absence of grade 3 or higher toxicity in the first cycle, a single, intra-patient dose increase to 20 mg temsirolimus will be permitted.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 13 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →New Mexico Cancer Research Alliance is the lead sponsor of 70 studies on the registry; 4 are open to participants now.
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Advanced disease, fulfilling one of the criteria defined below:
Platinum-refractory or platinum-ineligible, fulfilling one of the criteria defined below:
Measurable disease based on response evaluation criteria in solid tumors (RECIST)
Adequate hematologic reserve and organ function
Exclusion Criteria:
Erlotinib (Tarceva) at 150 mg by mouth daily + Temsirolimus (Torisel) at 15 mg intravenously weekly. Each cycle is comprised of 28 days
Drug: Erlotinib · Drug: Temsirolimus
Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.
Also known as: Tarceva, OSI-774
In the absence of Grade 3 or higher toxicity, a single, intra-patient dose increase of temsirolims to 20 mg intravenously weekly is permitted after the first 28 day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.
Also known as: Torisel, CCI-779
Progression Free Survival (PFS)
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.
Time frame: 3 years
Toxicity Profile
Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.
Time frame: 3 years
Overall Response Rate (ORR)
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses
Time frame: 3 years
Overall Survival (OS)
The time from treatment initiation to death by any cause
Time frame: 3 years
Dates of recruitment period: December, 2009 - March, 2011
| Milestone | Erlotinib and Temsirolimus |
|---|---|
| Started | 13 |
| Received treatment | 12 |
| Completed | 6 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 5 |
| Withdrew: Treatment-unrelated death | 1 |
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.
| Months | Erlotinib and Temsirolimus |
|---|---|
| Progression Free Survival (PFS) | 1.9 (0.6 to 7.4) |
Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.
| participants | Erlotinib and Temsirolimus |
|---|---|
| Diarrhea | 2 |
| Facial/neck edema | 1 |
| Laryngeal edema | 1 |
| Asthenia | 5 |
| Peritonitis / infection | 2 |
| Anorexia | 1 |
| Elevated triglycerides | 1 |
| Aspiration pneumonia | 1 |
| Dyspnea | 3 |
| Hypoxia | 1 |
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses
| percentage of evaluable participants | Erlotinib and Temsirolimus |
|---|---|
| Complete response (CR) | 0 |
| Partial response (PR) | 11.1 |
| Overall response rate (CR + PR) | 11.1 |
The time from treatment initiation to death by any cause
| months | Erlotinib and Temsirolimus |
|---|---|
| Overall Survival (OS) | 4 (0.6 to 20.2) |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib and Temsirolimus | — | 4/12 (33.3%) | 12/12 (100%) |
| Event | Erlotinib and Temsirolimus |
|---|---|
| Device related infectionInfections and infestations | 1/12 |
| Cerebrovascular IschemiaNervous system disorders | 1/12 |
| Adult respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 1/12 |
| Dyspnea (Shortness of breath)Respiratory, thoracic and mediastinal disorders | 1/12 |
| DeathGeneral disorders | 1/12 |
| Event | Erlotinib and Temsirolimus |
|---|---|
| FatigueGeneral disorders | 10/12 |
| RashSkin and subcutaneous tissue disorders | 7/12 |
| DiarrheaGastrointestinal disorders | 6/12 |
| Ear, nose and throat examination abnormalGeneral disorders | 6/12 |
| NauseaGastrointestinal disorders | 5/12 |
| Edema: head and neckGeneral disorders | 4/12 |
| Hypokalemia (Low potassium levels)Investigations | 4/12 |
| Platelets decreasedBlood and lymphatic system disorders | 3/12 |
| ConstipationGastrointestinal disorders | 3/12 |
| Gingival infection (Gum infection)Infections and infestations | 3/12 |
| Age, Continuous(years) | Erlotinib and Temsirolimus |
|---|---|
| Median | 61.5 (45 to 87) |
| Sex: Female, Male(Participants) | Erlotinib and Temsirolimus |
|---|---|
| Female | 1 |
| Male | 12 |
This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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