Paclitaxel, Carboplatin, and Dimethylxanthenone Acetic Acid in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer Read More

DISEASE CHARACTERISTICS:

• Histologically (preferred) or cytologically confirmed small-cell lung carcinoma (SCLC) by surgical biopsy, brushing, washing, OR core needle aspiration (sputum cytology alone not acceptable)

  • Extensive stage or stage IV disease, including patients with malignant pleural or pericardial effusion

    • No pleural effusion that causes ≥ CTC grade 2 dyspnea
• Not suitable for potentially curative combined-modality treatment for this disease
• Measurable or non-measurable disease
• No CNS metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Hemoglobin ≥ 10.0 g/dL
• Absolute neutrophils ≥ 2.0 x 10^9/L (without the use of growth factors)
• Platelet count ≥ 100 x 10^9/L
• Bilirubin ≤ 1.5 x the upper limit of normal (ULN)
• ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)
• Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)
• Creatinine clearance ≥ 45 mL/min
• INR ≤ 1.5
• Magnesium, potassium, and calcium (corrected for albumin) normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after completion of study therapy
• No recent hemoptysis associated with SCLC (> 1 teaspoon in a single episode within 4 weeks)
• No other malignancy within the past 5 years except for nonmelanoma skin cancer or cervical cancer in situ

• Must not have a history of any of the following conditions:

  • Myocardial infarction within the past 12 months
  • Uncontrolled hypertension (systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg) or poor compliance with anti-hypertensive regimen
  • Sustained ventricular tachycardia
  • Ventricular fibrillation or Torsades de Pointes
  • Long QT syndrome
  • QTc of > 450 msec
  • NYHA class III or IV congestive heart failure
  • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
  • Right bundle branch block and left anterior hemiblock (bifascicular block)
  • Bradycardia (defined as heart rate < 50 beats per minute)
  • Cardiac arrhythmias (i.e., symptomatic, but may not require medications) CTCAE grade ≥ 2
• No significant neurologic or psychiatric disorder that would compromise study participation
• No peripheral sensory neuropathy with functional impairment ≥ CTC grade 2 (regardless of cause)

• No concurrent severe and/or uncontrolled medical disease, including any of the following:

  • Uncontrolled diabetes
  • Chronic renal disease
  • Chronic liver disease
  • Confirmed diagnosis of HIV infection
  • Active uncontrolled infection
• No serious underlying medical condition, in the judgment of the investigator, that would impair the patient's ability to participate in the trial
• No known hypersensitivity to study drugs or to any other component of the study drugs (taxanes or other drugs formulated in Cremophor EL [polyoxyethylated castor oil])

PRIOR CONCURRENT THERAPY:

• Recovered from all prior therapy
• No prior systemic chemotherapy, immunotherapy, or biologic anti-cancer therapy

• More than 2 weeks since prior and no concurrent radiotherapy

  • Localized palliative radiotherapy to symptomatic bone metastases allowed

• More than 2 weeks since minor surgery

  • Insertion of a vascular access device allowed
• More than 3 weeks since prior dimethylxanthenone acetic acid for prophylactic cranial irradiation
• More than 4 weeks since major surgery (defined by the use of general anesthesia)
• At least 30 days since prior and no other concurrent investigational drugs or anti-cancer therapy
• No treatment in a clinical trial within 30 days prior to trial entry
• No concurrent therapy with a risk of causing Torsades de Pointes
• No concurrent drugs that would be contraindicated for use with study drugs
• No factors with the potential to prolong QT interval