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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Pemetrexed

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