Phase 2 N=46 Treatment

Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00280150 ↗

Enrolled (actual)

Serious AEs

42.2%

Results posted

Jun 2017

Primary outcome: Primary: Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) — 0; 0; 2 DLTs

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab (Biological); carboplatin (Drug); erlotinib hydrochloride (Drug); paclitaxel (Drug); 3-dimensional conformal radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UNC Lineberger Comprehensive Cancer Center
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])	0; 0; 2	—
PRIMARY Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy	4; 17; 52; 35; 0; 16	—
SECONDARY Progression-free Survival (PFS)	10.2	—
SECONDARY Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)	—	—
SECONDARY Overall Response Rate and Survival Profile	39	—
SECONDARY Feasibility and Tolerability of Administering Consolidation Therapy	5	—

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bevacizumab, radiation therapy, and erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bevacizumab and erlotinib when given together with combination chemotherapy and radiation therapy and to see how well they work in treating patients with stage III non-small cell lung cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of non-small cell lung cancer
Stage IIIA or IIIB disease
No malignant pleural or pericardial effusions
No palpable supraclavicular adenopathy
Squamous cell histology allowed provided there is no hemoptysis and no central invasive lesions that abut or invade major blood vessels in the chest (with or without cavitation)
Considered suitable and appropriate for combined modality therapy and thoracic conformal radiotherapy, as determined by the treating medical and radiation oncologist

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Hemoglobin ≥ 9.0 mg/dL
Platelet count ≥ 100,000/mm³
Absolute neutrophil count (ANC) ≥ 1,500/mm³
Forced expiratory volume 1 (FEV\_1) ≥ 1 L
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN
Bilirubin normal
Partial thromboplastin time (PTT) and international normalized ratio (INR) normal
Urine protein: creatinine ratio ½ teaspoon of bright red blood)
No unstable angina
No New York Heart Association (NYHA) congestive heart failure ≥ class II
No myocardial infarction or stroke within the past 6 months
No clinically significant peripheral vascular disease
No evidence of bleeding diathesis or coagulopathy
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No serious, non-healing wound, ulcer, or bone fracture
No thrombosis requiring therapeutic anticoagulation
No significant traumatic injury within the last 28 days

PRIOR CONCURRENT THERAPY:

Recovered from prior surgery
At least 4 weeks since prior and no concurrent participation in another experimental drug study
At least 4 weeks since prior and no concurrent major surgical procedure or open biopsy
At least 2 weeks since prior mediastinoscopy or mediastinotomy
At least 1 week since prior fine needle aspirations or core biopsies
No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
No other concurrent investigational agents

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00280150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.