Clinical trial · Interventional
Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.
- 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)
Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine and Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine and Docetaxel
- description
- Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
- interventionNames
- Drug: Gemcitabine and Docetaxel
Primary outcomes (1)
- measure
- Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
- timeFrame
- 2 & 4 months
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- time from study entry to death from any cause
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced NSCLC. * Stage III with pleural effusion and stage IV. * Patients are 70 years old. * Patients with 1 \> ECOG PS =1. * Patients must have at least one measurable lesion, no previously irradiated. * Life expectancy of at least 12 weeks. * Adequate organ function according to the following criteria: * Bone marrow: ANC \>= 2.0x10(9)cells/L; Platelet count \>= 100x10(9)cells/L; Leukocyte count \>= 4000x10(6)/L; Hemoglobin \>= 10 g/dL. * Liver function: Bilirubin \<= 1.5 X ULN; Alkaline phosphatase \<= 5 x ULN;AST and ALT \<= 1.5 x ULN. * Renal function: serum creatinine \<= 2mg/dL. Exclusion Criteria: * Prior systemic chemotherapy for advanced disease. * Patients with symptomatic brain metastases. * No measurable bone metastases or malignant pleural effusion as only measurable lesion. * History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years. * History of hypersensitivity reaction to study drugs. * Concurrent treatment with other experimental drugs. * Current peripheral neuropathy NCI grade 2. * Participation in clinical trials within 30 days of study entry. * Major surgery, open biopsy or traumatic lesion 28 days before to study start.
References
Publications (0)
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