Know Cancer

or
forgot password

A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Non Small Cell Lung Cancer, Failed Prior Chemotherapy

Thank you

Trial Information

A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy


Only patients with 0 to 1 performance status on the ECOG scale are eligible.


Inclusion Criteria:



- Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or
cytological).

- Received prior chemotherapy treatment for advanced, metastatic non-small cell lung
cancer.

- Measurable disease per RECIST criteria.

- Adequate bone marrow, hepatic and renal function.

Exclusion Criteria:

- Breast cancer or skin cancer at any time in the past or any other cancer in the past
5 years.

- Brain metastases that are unstable, require steroids, are life-threatening or
required radiation in the last 28 days.

- Known hypersensitivity to minocycline.

- History of serious cardiac disease that is not controlled.

- Serious eye conditions.

- Prior treatment with inhibitors of EGFR of any kind.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate

Outcome Time Frame:

3 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

OSI-774-202

NCT ID:

NCT00072631

Start Date:

August 2003

Completion Date:

March 2006

Related Keywords:

  • Advanced Non Small Cell Lung Cancer
  • Failed Prior Chemotherapy
  • Tarceva
  • erlotinib
  • NSCLC
  • Non-Small Cell Lung Cancer
  • EGFR
  • OSI-774
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Institute for Drug Development Cancer Therapy and Research CenterSan Antonio, Texas  78229