Clinical trial · Interventional
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
NCT00062062CI-TRIAL-00025142completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| gefitinib | Drug | Gefitinib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gefitinib
- description
- Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after the completion of course 2. Patients are followed every 3 months for 5 years.
- interventionNames
- Drug: gefitinib
- type
- EXPERIMENTAL
- label
- paclitaxel + carboplatin + gefitinib
- description
- 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.
- interventionNames
- Drug: carboplatin
- Drug: gefitinib
- Drug: paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMc Kean H, Stella PJ, Hillman SL, Rowland KM, Cannon MW, Behrens RJ, Gross GG, Sborov MD, Friedman EL, Jatoi A. Exploring therapeutic decisions in elderly patients with non-small cell lung cancer: results and conclusions from North Central Cancer Treatment Group Study N0222. Cancer Invest. 2011 May;29(4):266-71. doi: 10.3109/07357907.2010.535061. Epub 2011 Feb 23. PMID 21345074