Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Conditions

• Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• carboplatin — DRUG
• erlotinib hydrochloride — DRUG
• paclitaxel albumin-stabilized nanoparticle formulation — DRUG
• radiation therapy — RADIATION

Study Details

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Key Dates

First listed

Nov 5, 2007

Start date

Mar 31, 2008

Status verified

Jan 2018

Primary completion

Jan 31, 2014

Completion

Jun 15, 2017

Study Design

Enrollment

78 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: paclitaxel + carboplatin + radiation + erlotinib
  Patients receive paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years

Primary Outcome Measure

Overall Survival at 12 Months [ Time Frame: At 12 months ]

Locations (99)

Find similar trials in Castro Valley, CA

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