Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

Conditions

• Lung Adenocarcinoma
• Lung Adenosquamous Carcinoma
• Malignant Pericardial Effusion
• Malignant Pleural Effusion
• Minimally Invasive Lung Adenocarcinoma
• Stage IIIB Lung Non-Small Cell Cancer AJCC v7
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Erlotinib — DRUG
  Given PO
• Erlotinib Hydrochloride — DRUG
  Given PO
• Paclitaxel — DRUG
  Given IV

Study Details

This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.

Key Dates

First listed

Aug 4, 2005

Start date

Aug 15, 2005

Status verified

Jul 2019

Primary completion

Jun 30, 2010

Completion

Nov 28, 2017

Study Design

Enrollment

188 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (erlotinib hydrochloride)
  Patients receive erlotinib hydrochloride PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (erlotinib hydrochloride, paclitaxel, carboplatin)
  Patients receive erlotinib hydrochloride as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.

Primary Outcome Measure

18 Weeks Progression Free Survival (PFS) Rate [ Time Frame: At 18 weeks ]

Locations (96)

Find similar trials in Castro Valley, CA

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