Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: carboplatin

Drug: pemetrexed disodium

Radiation: radiation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00227565

NCI-2012-02671 (Registry Identifier)

NCCTG-N0423

CDR0000442866 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer.

Full description

OBJECTIVES:

Primary

Determine the complete and partial response rates in patients with previously untreated, extensive-stage small cell lung cancer treated with pemetrexed disodium and carboplatin.

Secondary

Determine the toxicity of this regimen in these patients.
Determine, preliminarily, the survival of patients treated with this regimen.
Determine, preliminarily, the response rate in patients 70 years and older treated with this regimen.
Determine, preliminarily, the toxicity of this regimen in patients 70 years and older.

OUTLINE: This is a multicenter study. Patients are stratified according to age (< 70 years vs ≥ 70 years).

Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: Approximately 77 patients at least 46 who are < 70 years of age and at least 24 who are ≥ 70 years of age) will be accrued for this study within 20-26 months.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell lung cancer
- Previously untreated disease
- No mixed histology
Extensive-stage disease
- Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
No symptomatic, untreated, or uncontrolled CNS metastases
- CNS metastases previously treated with whole-brain radiotherapy allowed

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 12 weeks

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL

Hepatic

Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR
Direct bilirubin normal
ALT and AST ≤ 3 times ULN (5 times ULN if there is liver involvement)

Renal

Creatinine clearance ≥ 45 mL/min

Cardiovascular

No angina pectoris
No congestive heart failure within the past 3 months, unless ejection fraction > 40%
No cardiac arrhythmia
No myocardial infarction within the past 3 months
No hypertension, including labile hypertension

Pulmonary

No interstitial pneumonia
No extensive and symptomatic interstitial fibrosis of the lung

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of poor compliance with antihypertensive medication
Able to take folic acid, cyanocobalamin (vitamin B_12) supplementation, or dexamethasone
No uncontrolled diabetes
No serious condition that would preclude study participation
No clinically significant infection
No significant traumatic injury
No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- Low-grade (Gleason score ≤ 6), localized prostate cancer allowed even if diagnosed < 5 years prior to study entry
No seizure disorder
No other severe and/or uncontrolled medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immunotherapy
No concurrent immunomodulating agents

Chemotherapy

No other concurrent chemotherapy

Endocrine therapy

No concurrent hormonal therapy

Radiotherapy

See Disease Characteristics
Prior palliative radiotherapy allowed
- No prior palliative radiotherapy to the chest except for ≤ 3 fractions for superior vena cava syndrome
No concurrent radiotherapy

Surgery

More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy
More than 2 weeks since prior minor surgery* NOTE: *Insertion of a vascular access device is not considered major or minor surgery

Other

More than 4 weeks since prior investigational therapy
No concurrent Hypericum perforatum (St. John's wort)
No concurrent inducers or inhibitors of CYP3A4
No concurrent medications that are metabolized by CYP3A4
No aspirin dose ≥ 1.3 grams per day for ≥ 10 days prior to and after study treatment
No other concurrent cytostatic or cytotoxic agents