Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Aug 15, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- University of Medicine and Dentistry of New Jersey
- Interventions being studied
- Drug: cisplatin; Drug: docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 malignancy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Central Jersey Oncology Center, PA - East BrunswickEast Brunswick, New Jersey
- JFK Medical Center in EdisonEdison, New Jersey
- CentraState Medical CenterFreehold, New Jersey
- Cancer Institute of New Jersey at HamiltonHamilton, New Jersey
- Monmouth Medical CenterLong Branch, New Jersey
- Mountainside Hospital Cancer CenterMontclair, New Jersey
- Jersey Shore University Medical CenterNeptune City, New Jersey
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey
- Saint Peter's University HospitalNew Brunswick, New Jersey
- UMDNJ - University HospitalNewark, New Jersey
- Raritan Bay Medical CenterPerth Amboy, New Jersey
- Somerset Medical CenterSomerville, New Jersey
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 15, 2023. Always confirm current availability with the study team.