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Completed PHASE2 INTERVENTIONAL NCT00032123

Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction

Sponsor: National Cancer Institute (NCI)

Updated 8 times since 2017 Last updated: Jun 21, 2013 Started: Jun 30, 2002 Completion: May 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00032123, this PHASE2 trial focuses on Esophageal Cancer and Gastric Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 8 times since 2002, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

OBJECTIVES: * Determine the overall response rate of patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with erlotinib. (Gastric stratum temporarily closed to accrual as of 03/01/2003.) * Determine the frequency and severity of toxic effects of this drug in these patients. * Determine the overall survival and time to treatment failure in patients treated with this drug. * Determine the value of intratumoral expression of epidermal growth factor receptor in predicting patient response to this drug. OUTLINE: This is a multicenter study. Patients are stratified according to cancer site (stomach vs gastroesophageal junction). (The gastric stratum is temporarily closed to accrual as of 03-01-2003.) Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this study within 14-40 months. (The gastric stratum is temporarily closed to accrual as of 03-01-2003.)

OBJECTIVES:

* Determine the overall response rate of patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with erlotinib. (Gastric stratum temporarily closed to accrual as of 03/01/2003.) * Determine the frequency and severity of toxic effects of this drug in these patients. * Determine the overall survival and time to treatment failure in patients treated with this drug. * Determine the value of intratumoral expression of epidermal growth factor receptor in predicting patient response to this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to cancer site (stomach vs gastroesophageal junction). (The gastric stratum is temporarily closed to accrual as of 03-01-2003.)

Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this study within 14-40 months. (The gastric stratum is temporarily closed to accrual as of 03-01-2003.)

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~May 2023 · 28 months · monthly snapshotCompleted~May 2023 – ~Jul 2024 · 14 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

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

    Completed PHASE2

  2. Sep 2025 — Present [monthly]

    Completed PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. May 2023 — Jul 2024 [monthly]

    Completed PHASE2

Show 3 earlier versions
  1. Jan 2021 — May 2023 [monthly]

    Completed PHASE2

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  3. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Jun 2002

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • SWOG Cancer Research Network
Data source: National Cancer Institute (NCI)

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