Phase 2 N=62 Treatment

Pemetrexed, Carboplatin, and Bevacizumab as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00798603 ↗

Enrolled (actual)

Serious AEs

16.1%

Results posted

Jan 2017

Primary outcome: Primary: Progression-free Survival at 6 Months — 60 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab (Biological); carboplatin (Drug); pemetrexed disodium (Drug)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival at 6 Months	60	—
SECONDARY Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations	40	—
SECONDARY Duration of Response	8.8	—
SECONDARY Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients	16; 7; 18; 11	—
SECONDARY Time to Treatment Failure	4.89	—
SECONDARY Progression-free Survival	7	—
SECONDARY Overall Survival	13.7	—
SECONDARY Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale	1.1	—
SECONDARY Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale	1.1	—
SECONDARY Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)	—	—
SECONDARY Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)	—	—
SECONDARY Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale	—	—
SECONDARY Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale	-10	—
SECONDARY Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale	—	—
SECONDARY Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale	—	—
SECONDARY Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale	—	—
SECONDARY Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale	—	—

Summary

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed nonsquamous cell non-small cell lung cancer (NSCLC)
Stage IIIB (with pleural effusion) or IV disease
Squamous cell carcinomas not allowed
Adenosquamous histology allowed
Clinically significant effusion (e.g., symptomatic pleural effusion or ascites) allowed provided it is drained before study treatment
No symptomatic pleural and/or peritoneal effusion (≥ grade 2 dyspnea, as defined by NCI CTCAE v3.0 criteria) that is not amenable to drainage
If effusion produces clinically significant measurable objective changes, such as hypoxia or estimated volume > 500 mL, effusion should be drained even if asymptomatic
Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
If the sole site of disease is in a previously irradiated field, must have evidence of disease progression/recurrence within the irradiated field OR presence of a new lesion outside the irradiated field
No symptomatic, untreated, or uncontrolled CNS metastases
CNS metastases that were previously treated with whole brain radiotherapy (WBRT) allowed
Willing to enroll in NCCTG-N0392

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy ≥ 12 weeks
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
AST and ALT ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)
Creatinine clearance ≥ 45 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Able to take folic acid, vitamin B\_12 supplementation, or dexamethasone
Able to complete questionnaire(s) alone or with assistance
Willing to provide biologic specimens as required by the study
Willing to return to NCCTG participating center for follow-up
No clinically significant infection
No serious, nonhealing wounds, ulcers, or bone fractures
No seizure disorder
No second primary malignancy within the past 5 years, except for any of the following:
Carcinoma in situ of the cervix
Nonmelanomatous skin cancer
History of melanoma allowed only if diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
Low-grade (Gleason score ≤ 6) localized prostate cancer (no nodal involvement)
Previously treated stage I breast cancer
No concurrent severe and/or uncontrolled medical condition, including any of the following:
Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
Angina pectoris
Congestive heart failure within the past 3 months, unless ejection fraction > 40%
Myocardial infarction within the past 6 months
Cardiac arrhythmia
Diabetes mellitus
Interstitial pneumonia or extensive, symptomatic interstitial fibrosis of the lung
Active or recent history of hemoptysis > ½ teaspoon per event
Ongoing or active infection
Psychiatric illness/social situation that would limit compliance with study requirements
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 12 months
No diverticulitis within the past 12 months
No stroke within the past 6 months
No significant traumatic injury within the past 8 weeks
Not at greater than normal risk of bleeding

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior radiotherapy to > 25% of bone marrow
More than 2 weeks since prior radiotherapy and recovered (alopecia allowed)
At least 2 weeks since prior WBRT
At least 3 days since prior gamma knife radiosurgery (without WBRT) for brain metastases
More than 4 weeks since prior administration of live or attenuated viral vaccine
More than 8 weeks since prior major surgery (e.g., laparotomy) or open biopsy (> 4 weeks since minor surgery)
Insertion of a vascular access dev

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00798603). 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.