Phase 2 N=51 Treatment

Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00234052 ↗

Enrolled (actual)

Serious AEs

44.0%

Results posted

May 2019

Primary outcome: Primary: Median Progression Free Survival — 7.8 Months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab (Biological); carboplatin (Drug); pemetrexed (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Progression Free Survival	7.8	—
SECONDARY Overall Response Rate	27	—
SECONDARY Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment	3; 4; 2; 3; 4; 4	—
SECONDARY Overall Survival Rate	14.1	—
SECONDARY Duration of Response	7.7	—

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically* or cytologically* confirmed non-small cell lung cancer
Any histology, except squamous cell carcinoma, allowed
Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible
No histology in close proximity to a major vessel or cavitation NOTE: *Histologic or cytologic elements may be established on metastatic tumor aspirates or biopsy
Meets 1 of the following stage criteria:
Stage IIIB disease (with malignant pleural effusion)
Stage IV disease
Recurrent disease
Measurable or non-measurable disease
No known CNS metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
No history of hemorrhagic disorders

Hepatic

Bilirubin 325 mg per day)
NSAIDs known to inhibit platelet function, including any of the following:
Dipyridamole
Ticlopidine
Clopidogrel
Cilostazol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00234052). 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.