Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Plus Carboplatin and Paclitaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0304051 IMMUNEX-054.0004, ABX-0304, AMGEN-20025404, NCT00034346

Objectives

Part 1

1. Determine the safety of monoclonal antibody ABX-EGF (MOAB ABX-EGF) administered with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer.
2. Determine the pharmacokinetics of this regimen in these patients.
3. Determine the clinical response in patients treated with this regimen.

Part 2

1. Compare time to disease progression in patients treated with carboplatin and paclitaxel with vs without MOAB ABX-EGF.
2. Compare the clinical efficacy of these regimens in these patients.
3. Compare the safety of these regimens in these patients.
4. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:
  • Stage IIIB with pericardial or pleural effusion
  • Stage IV



• Epidermal growth factor receptor overexpression by immunohistochemistry (1+, 2+, or 3+ in at least 10% of evaluated tumor cells)



• Bidimensionally measurable disease
  • At least 20 mm x 10 mm by conventional techniques OR at least 10 mm x 10 mm by spiral CT scan
  • If the only site of measurable disease has been previously irradiated there must be disease progression in that site



• Brain metastases allowed provided they are controlled and asymptomatic with no steroid therapy for at least 1 week

Prior/Concurrent Therapy:

Biologic therapy

• No prior anti-epidermal growth factor receptor (EGFR) therapy
• No other concurrent anti-EGFR therapy

Chemotherapy

• Not specified

Endocrine therapy

• See Disease Characteristics
• Prior steroid therapy for NSCLC allowed

Radiotherapy

• See Disease Characteristics
• More than 2 weeks since prior radiotherapy
• Concurrent local radiotherapy to bone lesions allowed provided no more than 10% of bone marrow is irradiated
  • No concurrent radiotherapy to lesions being evaluated to assess response

Surgery

• Prior surgery for NSCLC allowed

Other

• More than 30 days since prior investigational therapy
• No other prior therapy for NSCLC
• No concurrent antihypercalcemic treatment as cancer therapy for bone disease
• No other concurrent investigational drugs
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
• AST and ALT no greater than 3 times ULN
• Bilirubin no greater than 1.5 times ULN

Renal

• Creatinine clearance greater than 15 mL/min
• Calcium no greater than ULN (treatment for hypercalcemia allowed)

Cardiovascular

• LVEF at least 45% by MUGA
• No symptomatic ventricular arrhythmia
• No symptomatic conduction abnormality
• No myocardial infarction within the past year

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 month after study participation
• HIV negative
• No chronic medical condition or laboratory abnormality that would preclude study participation or compliance
• No psychiatric condition that would preclude study participation or compliance
• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
• No hypersensitivity to any ingredients of the study drug or Staphylococcus A protein

Expected Enrollment

A total of 240-255 patients (15-30 for part 1 and 225 for part 2 [75 for arm I and 150 for arm II]) will be accrued for this study within 9 months.

Outline

This is an open-label, multicenter, dose-escalation study of monoclonal antibody ABX-EGF (MOAB ABX-EGF) followed by a randomized study.

• Part 1: Patients receive MOAB ABX-EGF IV over 1 hour once weekly for 6 weeks. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once on weeks 0 and 3.

  Cohorts of 5-10 patients receive escalating doses of MOAB ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 or 4 of 10 patients experience dose-limiting toxicity.




• Part 2: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive paclitaxel and carboplatin as in part 1.
  
  
  
  • Arm II: Patients receive paclitaxel and carboplatin as in part I and MOAB ABX-EGF as in part 1 at the MTD.
  
  
  

  At 6 weeks, patients with an objective response (partial or complete response) or stable disease may receive extended therapy comprising paclitaxel and carboplatin once every 3 weeks and MOAB ABX-EGF weekly as above. Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 6, 12, 18, 24, 30, 36, and 42.

Patients are followed within 4 weeks and then every 3 months for 2 years.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Diane Prager, MD, Principal investigator(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719

Registry Information
Official Title		A Two Part, Multiple Dose Clinical Trial Of The Safety And Efficacy Of ABX-EGF In Combination With Paclitaxel And Carboplatin In Patients With Advanced Non-Small Cell Lung Cancer
Trial Completion Date		2007-12-20
Registered in ClinicalTrials.gov		NCT00034346
Date Submitted to PDQ		2003-07-28
Information Last Verified		2004-05-18
NCI Grant/Contract Number		CA16042

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