A Phase 2 interventional study of Erlotinib and Platinum-based chemotherapy in Carcinoma, Non-Small-Cell Lung, sponsored by New Mexico Cancer Research Alliance. Terminated at 5 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-17.
Sponsored by New Mexico Cancer Research Alliance · Phase 2, Interventional, and Treatment
This study was conducted to compare the activities of erlotinib to that of intravenous, platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline therapy, compared to historical controls.
To compare the activities (the progression-free survival, the incidence and severity of toxicities, and reversibility of toxicities) of erlotinib to that of platinum-based therapy in NSCLC. A sequential therapy design has been chosen such that all patients will receive any potential benefits of both platinum-based and erlotinib therapy, without compromising survival by denying anyone potential therapy. With this design, progression-free survival will be tracked by treatment received. However, data will be generated which will show the safety and efficacy of erlotinib in the frontline setting (alone and with historical comparison to platinum-based therapy), as well as the potential safety and activity of platinum-based therapy in the "second-line" (post-erlotinib) setting. This should allow for the demonstration of the relative median time to progression, objective response and clinical benefit rates, overall survival, and safety and tolerability of erlotinib and platinum-based therapy in both the frontline and second-line settings in NSCLC. Also, in this fashion, the treatments serve as controls for each other, as well as being compared to historical controls; in the first line treatment portion, the platinum-based regimens serve as the historical control, while in the second-line setting, erlotinib serves as the historical control arm.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 45 is close to 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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Baseline laboratory values (bone marrow, renal, hepatic):
Adequate bone marrow function:
Renal function:
Hepatic function:
Other Eligibility Criteria:
Exclusion Criteria:
Erlotinib: 150 mg orally once daily, Platinum-based chemotherapy regimen selections include: Carboplatin (Carbo) area under the curve (AUC) 6, or cisplatin (Cis) 60-100 mg/m2, day (D)1, administered with one of the following: 1. Docetaxel 75 mg/m2, D1 2. Docetaxel 35 mg/m2, D1,8,15 3. Paclitaxel 200-225 mg/m2, D1 4. Paclitaxel 80-100 mg/m2, D1,8,15 Carbo AUC 5-6, or Cis 60-100 mg/m2, D1, administered with one of the following: 1. Etoposide 100 mg/m2 D1-3 2. Etoposide 200 mg/m2 orally D1-3 3. Pemetrexed 500 mg/m2, D 1 4. Irinotecan 50 mg/m2 D1,8,15 Other regimens: 1. Gemcitabine 1000 mg/m2-1250 mg/m2, D1,8 + Carbo AUC 6, or Cis 60-100 mg/m2, D1 or 8 2. Vinorelbine 25 mg/m2 D1,8 + Carbo AUC 5, or Cis 80 mg/m2 D1
Drug: Erlotinib · Drug: Platinum-based chemotherapy
Erlotinib will be administered for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or intolerance to erlotinib, standard of care platinum-based chemotherapy (per the choice of the treating physician) is administered every 3 weeks. Physicians can adjust dose, schedule, or supportive care to the benefit of the patient
Also known as: Tarceva, OSI-774
Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles
Also known as: paclitaxel + platinum, docetaxel + platinum, vinorelbine + platinum, pemetrexed + platinum, irinotecan + platinum, etoposide + platinum, gemcitabine + platinum
Progression-free Survival (PFS)
Time frame: 5 years
Toxicity Profile
Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.
Time frame: 28 days after last on-study treatment
Recruitment began 07/13/2006 and ended 02/09/2009. All patients were recruited through medical clinics in New Mexico, USA.
| Milestone | Erlotinib Followed by Chemotherapy |
|---|---|
| Started | 45 |
| Received first-line erlotinib | 43 |
| Received platinum-based chemotherapy | 10 |
| Completed | 21 |
| Not completed | 24 |
| Withdrew: Progressive disease | 13 |
| Withdrew: Adverse event | 5 |
| Withdrew: Physician decision | 2 |
| Withdrew: Death | 4 |
No measurements were reported for this outcome.
Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.
| participants | Erlotinib Followed by Chemotherapy |
|---|---|
| Acne | 1 |
| Anorexia | 1 |
| Confusion | 1 |
| Dehydration | 1 |
| Diarrhea | 2 |
| Dyspnea | 3 |
| Fatigue | 8 |
| Nasal hemorrhage | 1 |
| Insomnia | 1 |
| Kidney pain | 1 |
| Lymphocyte count decreased | 1 |
| Muscle weakness | 1 |
| Neutrophil count decreased | 2 |
| Desquamating rash | 1 |
| Syncope | 1 |
| Thrombosis (clotting) | 1 |
Collected over Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib Followed by Chemotherapy | — | 5/43 (11.6%) | 25/43 (58.1%) |
| Event | Erlotinib Followed by Chemotherapy |
|---|---|
| Glucose intoleranceEndocrine disorders | 1/43 |
| SeizureNervous system disorders | 1/43 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/43 |
| Thrombosis (Clotting)Blood and lymphatic system disorders | 1/43 |
| Ear, nose, and throat examination abnormalGeneral disorders | 1/43 |
| DeathGeneral disorders | 1/43 |
| Event | Erlotinib Followed by Chemotherapy |
|---|---|
| FatigueGeneral disorders | 13/43 |
| AcneSkin and subcutaneous tissue disorders | 9/43 |
| DiarrheaGastrointestinal disorders | 9/43 |
| NauseaGastrointestinal disorders | 9/43 |
| Anorexia (loss of appetite)Gastrointestinal disorders | 8/43 |
| Dyspnea (Shortness of breath)Respiratory, thoracic and mediastinal disorders | 8/43 |
| RashSkin and subcutaneous tissue disorders | 7/43 |
| Taste alterationGastrointestinal disorders | 7/43 |
| Alopecia (Hair loss)Skin and subcutaneous tissue disorders | 5/43 |
| ConstipationGastrointestinal disorders | 5/43 |
These are patients who received at least one dose of on-study erlotinib
| Age, Continuous(years) | Erlotinib Followed by Chemotherapy |
|---|---|
| Median | 68 (46 to 85) |
| Sex: Female, Male(Participants) | Erlotinib Followed by Chemotherapy |
|---|---|
| Female | 23 |
| Male | 20 |
| Region of Enrollment(participants) | Erlotinib Followed by Chemotherapy |
|---|---|
| United States | 43 |
This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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