Clinical trial · Interventional
Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
- 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: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (4)
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Tolerability
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes: * Epidermoid carcinoma * Large cell carcinoma * Adenocarcinoma * Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease * Inoperable disease * Measurable disease * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than normal * Transaminases no greater than 1.5 times normal * Alkaline phosphatase no greater than 2.5 times normal Renal * Creatinine no greater than 2.3 mg/dL Cardiovascular * No uncontrolled cardiac insufficiency Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study therapy * No uncontrolled infection * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No grade 3 or 4 brain disorder * No intolerance to polysorbate 80 or cortisones PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy, including taxanes or gemcitabine * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to more than 20% of the bone marrow * No prior radiotherapy for lung cancer * At least 4 weeks since other prior radiotherapy and recovered Surgery * No prior surgery for lung cancer Other * More than 30 days since prior clinical trial participation
References
Publications (0)
Data not yet available