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)
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
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
May 2023 — Jul 2024 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jan 2021 — May 2023 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
-
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
- National Cancer Institute (NCI)
- SWOG Cancer Research Network
For direct contact, visit the study record on ClinicalTrials.gov .