Clinical trial NCT00391586
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: erlotinib NSCLC chemotherapy platinum lung lung cancer
Sponsor: New Mexico Cancer Research Alliance
Start date: 2006-07-01; Completion date: 2012-05-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: 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
Interventions: intervention 1: Erlotinib intervention 2: Platinum-based chemotherapy
Intervention descriptions: intervention 1: 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 intervention 2: Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles

Protocol documents: