Clinical trial · Interventional
Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer
NCT00118131CI-TRIAL-00068804terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage III 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)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel and Cisplatin
- description
- A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
- interventionNames
- Drug: cisplatin
- Drug: docetaxel
Primary outcomes (1)
- measure
- Overall Tumor Response Rate
- timeFrame
- 7 years
- description
- Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:
* Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following:
* Positive cytology
* Exudative effusion AND lactic dehydrogenase (LDH) \> 200 IU with effusion/serum LDH ratio ≥ 0.6
* Stage IV disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
* Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
Hepatic
* AST and ALT normal
* Bilirubin normal
Renal
* Creatinine clearance ≥ 50 mL/min
Immunologic
* No known HIV positivity
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No clinically significant active infection
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment
* No other primary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious systemic disorder that would preclude study participation
* No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal growth factor receptor \[EGFR\]) allowed provided there is disease progression during therapy and patient has recovered
* No concurrent immunotherapy
* No concurrent prophylactic colony-stimulating factors
* No concurrent interleukin-11
Chemotherapy
* No prior cytotoxic chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy for the malignancy
Radiotherapy
* See Disease Characteristics
* More than 28 days since prior radiotherapy and recovered
* No prior radiotherapy to ≥ 25% of the bone marrow
* No prior radiotherapy to sites of measurable disease unless there is documented tumor progression after completion of radiotherapy
* No concurrent radiotherapy
Surgery
* No concurrent surgery for the malignancy
Other
* More than 3 weeks since prior investigational drugs
* Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR) allowed provided there is disease progression during therapy and patient has recovered
* No other concurrent investigational or commercial agents or therapies for the malignancyReferences
Publications (0)
Data not yet available
No reference posted for this study.