CALGB 30801: A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

Study Status

Closed to Enrollment

Study Description

The purpose of this study is to determine if there is a benefit from adding an experimental drug called celecoxib to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

As part of the screening proces for this study, we will test a sample of a participant's cancer to see if it has an enzyme called COX-2. Recent studies have shown that people who have high levels of COX-2 in tumor tissue appear to benefit from treatment with celecoxib or similar drugs. If the test shows that a participant's tumor does not have a high level of COX-2, he/she will not be eligibile for this study, and the participant and his/her physician would decide on a treatment strategy outside of this study.

Participants in this study will be randomly assigned to one of two study groups:

  • Group A: Treatment with one of the below combinations, depending on the type of lung cancer a participant has: 
    • Gemcitabine infusion on days 1 and 8 of each treatment cycle
    • Carboplatin infusion immediately after the gemcitabine on day 1
    • Celecoxib capsule by mouth 2 times daily for as long as you are on the study
      • Or
    • Pemetrexed infusion on day 1
    • Carboplatin infusion immediately after the pemetrexed on day 1
    • Celecoxib capsule by mouth 2 times daily for as long as you are on the study
  • Group B: Treatment with one of the below combinations, depending on which type of lung cancer a participant has:
    • Pemetrexed infusion on day 1
    • Carboplatin infusion immediately after the pemetrexed on day 1
    • Celecoxib capsule by mouth 2 times daily for as long as you are on the study
      • Or
    • Pemetrexed infusion on day 1
    • Carboplatin infusion immediately after pemetrexed on day 1
    • Placebo capsule by mouth 2 times daily for as long as you are on the study

The treatment will be repeated every 21 days. Participants may receive up to 6 cycles of treatment. When the 6 cycles are over a participant may take the celocoxib/placebo for as long as their tumor does not grow.

Disease Status and/or Stage

Non Small Cell Lung Cancer (NSCLC)

Sponsor

CALGB

Key Eligibility

  • Men and women age 18 and older
  • Non-small cell lung cancer (NSCLC)
  • No prior chemotherapy, immunotherapy or systemic treatments for NSCLC; ≥2 weeks since radiation therapy or surgery and completely recovered from these treatments
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Bryan Schneider, MD

Contact

Protocol ID

CALGB 30801

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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