Clinical trial · Interventional
BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer
An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
NCT00054314CI-TRIAL-00061038completedPhase 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ortataxel | Drug | — | UNRESOLVED |
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
* Measurable disease
* A CNS lesion cannot be the sole target lesion
* Must be taxane-resistant as defined by the following criteria:
* At least 1 prior course (3 weeks of continuous therapy) of a taxane
* Progressive disease developed either during or within 6 months after therapy
* No metastatic brain or meningeal tumors unless the following criteria apply:
* More than 6 months since definitive therapy
* Negative imaging study within the past 4 weeks
* Clinically stable with respect to the tumor
* No concurrent acute steroid therapy or taper
* Chronic steroids allowed provided dose is stable for 1 month before and after screening radiography
PATIENT CHARACTERISTICS:
Age
* 18 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 9.0 g/dL
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT and AST no greater than 2.5 times ULN (5 times ULN if liver involvement)
* No chronic hepatitis B or C
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No congestive heart failure
* No serious cardiac arrhythmias
* No active coronary disease or ischemia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* HIV negative
* No active clinically serious infection
* No history of seizure disorder
* History of seizures related to brain metastasis allowed if seizure free for the past 2 months
* No prior hypersensitivity to taxane compounds that was unmanageable with premedication
* No pre-existing peripheral neuropathy greater than grade 1
* No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, and T1)
* No substance abuse
* No medical, psychological, or social condition that would preclude study participation or evaluation
* No condition that is unstable or would jeopardize patient safety and study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 3 weeks since prior anticancer immunotherapy
* More than 3 weeks since prior biologic response modifiers (e.g., filgrastim \[G-CSF\])
* More than 4 months since prior bone marrow transplantation or stem cell rescue
* No concurrent anticancer immunotherapy
* Concurrent epoetin alfa allowed if dose is stable for the past 2 months
Chemotherapy
* See Disease Characteristics
* More than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas)
* No more than 2 prior anticancer chemotherapy regimens (adjuvant therapy is not included unless cancer recurred during or within 6 months after completion of adjuvant therapy)
* No prior oxaliplatin
* No other concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* More than 3 weeks since prior radiotherapy
* No concurrent non-palliative radiotherapy
* Palliative radiotherapy allowed provided that all of the following criteria are met:
* No progressive disease
* No more than 10% of the bone marrow is irradiated
* Radiation field does not encompass a target lesion
Surgery
* More than 4 weeks since prior surgery
* No prior organ allograft
Other
* More than 4 weeks since prior investigational drug therapy
* No concurrent non-conventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements that would interfere with study endpoints
* No other concurrent investigational drug therapy
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.