Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Dec 14, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: carboplatin; Drug: gefitinib; Drug: paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic ScottsdaleScottsdale, Arizona
- Front Range Cancer SpecialistsFort Collins, Colorado
- Mayo Clinic - JacksonvilleJacksonville, Florida
- Rush-Copley Cancer Care CenterAurora, Illinois
- St. Joseph Medical CenterBloomington, Illinois
- Graham HospitalCanton, Illinois
- Memorial HospitalCarthage, Illinois
- St. Anthony's Memorial HospitalEffingham, Illinois
- Eureka Community HospitalEureka, Illinois
- Galesburg ClinicGalesburg, Illinois
- Galesburg Cottage HospitalGalesburg, Illinois
- Mason District HospitalHavana, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 14, 2016. Always confirm current availability with the study team.