deltatrials
Unknown PHASE2 INTERVENTIONAL NCT00514293

Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer

Sponsor: Raghu Nandan, M.D., Inc

Conditions Lung Cancer
Updated 7 times since 2017 Last updated: Jan 9, 2014 Started: Jan 31, 2007 Primary completion: Dec 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Lung Cancer and is currently ongoing. Raghu Nandan, M.D., Inc leads this study, which shows 7 recorded versions since 2007 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

OBJECTIVES: Primary * Evaluate the efficacy of bexarotene at a dose of 375 mg daily for 4 days with tretinoin also for the same 3 days with chemotherapy in patients with advanced non-small cell lung cancer. * Evaluate the safety and tolerability of this drug combination. OUTLINE: Patients will receive oral bexarotene 375 mg once daily and oral tretinoin 50 mg twice daily on days 1-3. Patients also receive combination chemotherapy comprising cisplatin or carboplatin with docetaxel and capecitabine orally or intravenously on days 1-3. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed every 4 weeks.

OBJECTIVES:

Primary

* Evaluate the efficacy of bexarotene at a dose of 375 mg daily for 4 days with tretinoin also for the same 3 days with chemotherapy in patients with advanced non-small cell lung cancer. * Evaluate the safety and tolerability of this drug combination.

OUTLINE: Patients will receive oral bexarotene 375 mg once daily and oral tretinoin 50 mg twice daily on days 1-3. Patients also receive combination chemotherapy comprising cisplatin or carboplatin with docetaxel and capecitabine orally or intravenously on days 1-3. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients will be followed every 4 weeks.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotUnknown Status~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE2

  2. Sep 2024 — Present [monthly]

    Unknown PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE2

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Unknown Status PHASE2

    First recorded

Jan 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Raghu Nandan, M.D., Inc
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations