Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-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: Albumin-Bound Paclitaxel; Carboplatin; Gefitinib; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Metastatic or unresectable disease

• Measurable disease

• At least 1 lesion at least 2.0 cm

• Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy

• No meningeal carcinomatosis

• No untreated brain metastases

• Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy

• No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy)

PATIENT CHARACTERISTICS:

Age

• 65 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10.0 g/dL

Hepatic

• Bilirubin no greater than 2.0 mg/dL

• No uncontrolled hepatic disease

Renal

• Creatinine no greater than 2 times upper limit of normal

• No uncontrolled renal disease

Cardiovascular

• No uncontrolled cardiac disease

Pulmonary

• No clinically active interstitial lung disease

• Asymptomatic, chronic stable radiographic changes allowed

• No uncontrolled respiratory disease

Other

• Fertile patients must use effective contraception

• Able and willing to complete questionnaires alone or with assistance

• No known hypersensitivity to gefitinib or any of its excipients

• No active infection within the past 2 weeks

• No other prior malignancy within the past 5 years except basal cell skin cancer

• No grade 2 or greater peripheral neuropathy (CTC v2.0)

• No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)

• No dysphagia or inability to swallow intact capsules

• No significant medical condition that would preclude study treatment or follow-up

• No severe or uncontrolled systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior chemotherapy for metastatic NSCLC

Endocrine therapy

• Concurrent steroids allowed provided the dose is not changed

Radiotherapy

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to more than 25% of marrow-containing skeleton

• No concurrent radiotherapy (including palliative)

Surgery

• See Disease Characteristics

• At least 3 weeks since prior major surgery

• No surgery within 7 days after study participation

Other

• More than 30 days since prior non-FDA approved investigational drugs

• No concurrent oral retinoids

• No concurrent CYP3A4-inducing agents, including the following:

• Carbamazepine

• Oxcarbazepine

• Modafinil

• Ethosuximide

• Griseofulvin

• Nafcillin

• Phenobarbital

• Phenylbutazone

• Phenytoin

• Primidone

• Rifampin

• Hypericum perforatum (St. John's wort)

• Barbiturates

• Sulfinpyrazone

• No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)

• No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration

• No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin