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

Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00062062
Enrollment
65
Registered
2003-06-06
Start date
2004-10-31
Completion date
2010-11-30
Last updated
2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer

Brief 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.

Detailed description

OBJECTIVES: Primary * Determine the 6-month progression status of older patients with unresectable or metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin and paclitaxel. Secondary * Determine the response rate in patients treated with these regimens. * Determine the quality of life of patients treated with these regimens. * Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR) concentrations predict response in patients treated with these regimens. * Correlate the presence of social support for these patients with toxicity and efficacy of these regimens. * Determine whether social support for these patients differs according to gender. * Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy regimen for these patients. Tertiary * Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of prespecified germline and tumor genes, and plasma and urine proteomic patterns with response rate and time to progression of patients receiving treatment in group I. OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment groups as determined by their treating physician. * Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I. Quality of life is assessed at baseline and after the completion of course 2. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be accrued for this study within 1.7 years.

Interventions

DRUGcarboplatin
DRUGgefitinib
DRUGpaclitaxel

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Progression status at 6 monthsat 6 months

Secondary

MeasureTime frame
Confirmed response rate (complete or partial response)Up to 5 years
Overall survivalUp to 5 years
Progression-free survivalUp to 5 years
Quality of life as assessed by the Lung Cancer Symptom scaleUp to 5 years
Social support measure as assessed by the Lubben Social Network scaleUp to 5 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026