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INST 0601C: A Randomized Phase II Protocol of Erlotinib Versus Standard Platinum-Based Chemotherapy in Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung


Phase 2
18 Years
80 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

INST 0601C: A Randomized Phase II Protocol of Erlotinib Versus Standard Platinum-Based Chemotherapy in Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung


Primary Objective:To compare the activities(the progression-free survival, and the incidence
and severity of toxicities, and reversibility of toxicities) of erlotinib to that of
platinum-based therapy in NSCLC


Inclusion Criteria:



- Prior chemotherapy will be allowed for other invasive malignancies, provided at least
five years has elapsed since the completion of therapy and enrollment on this
protocol. No prior chemotherapy for metastatic NSCLC will be allowed. Prior adjuvant
or neoadjuvant chemotherapy for NSCLC will be allowed, provided at least six months
have elapsed from the last dose of chemotherapy to the documentation of relapsed
disease.

Baseline laboratory values (bone marrow, renal, hepatic):

- Adequate bone marrow function:

- Absolute neutrophil count >1000/µL

- Platelet count >100'000/µL

- Renal function:

- Serum creatinine < 2.0 mg %

- Hepatic function:

- Bilirubin <1.5x normal

- Serum calcium < 12 mg/dl

Other Eligibility Criteria:

- Signed Informed Consent

- ECOG/Zubrod/SWOG Performance Status <2 (Karnofsky Performance Status > 70%)

- Life expectancy > 8 weeks

- Male or female' age >18 years

- Patients of childbearing potential must be using an effective means of contraception.

- Histologic diagnosis of NSCLC that is advanced and cannot be treated adequately by
radiotherapy or surgery; or metastatic disease

Exclusion Criteria:

- Prior therapy with an epidermal growth factor receptor inhibitor, including
erlotinib, gefitinib, and cetuximab, as well as any investigational HER-1 inhibiting
agent

- Pregnant or lactating females

- Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0

- Uncontrolled' clinically significant dysrhythmia

- History of prior malignancy within the prior five years, with the exception of
non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix

- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor
growth in that lesion

- Uncontrolled metastatic disease of the central nervous system (previously treated,
stable disease is allowable on this protocol)

- Radiotherapy within the 2 weeks before Cycle 1' Day 1

- Surgery within the 2 weeks before Cycle 1' Day 1

- Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response, clinical benefit, tumor responses + stable disease

Outcome Time Frame:

disease progress or complete remission

Safety Issue:

Yes

Principal Investigator

Dennie V Jones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

INST 0601C

NCT ID:

NCT00391586

Start Date:

July 2006

Completion Date:

May 2012

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • erlotinib
  • NSCLC
  • chemotherapy
  • platinum
  • lung
  • lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Hematology Oncology Associates NMAlbuquerque, New Mexico  87106
Lovelace Medical GroupAlbuquerque, New Mexico  87102
Presbyterian Medical GroupAlbuquerque, New Mexico  87110