Clinical trial · Interventional
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
NCT00081107CI-TRIAL-00010602completedPhase 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, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
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 |
|---|---|---|---|
| epothilone D | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB\* or IV disease NOTE: \*Due to malignant pleural effusion or supraclavicular lymph node involvement only * Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease * Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity * At least 1 site of unidimensionally measurable disease by physical exam or radiography * No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8 g/dL * Platelet count ≥ 75,000/mm\^3 Hepatic * AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) * Alkaline phosphatase ≤ 5 times ULN * Bilirubin ≤ 1.8 mg/dL Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No personal or family history of congenital long QT syndrome * No QTc interval \> 450 msec (males) or \> 470 msec (females) by ECG Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No preexisting neuropathy ≥ grade 2 * No other malignancy within the past 5 years except for the following: * Cured basal cell skin cancer * Carcinoma in situ of the cervix or urinary bladder * Stage T1 or T2 prostate cancer with prostate-specific antigen \< 2 ng/mL * No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy * No infection requiring parenteral or oral anti-infective therapy * No weight loss of ≥ 10% within the past 3 months * No altered mental status or psychiatric illness that would preclude giving informed consent * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim \[GM-CSF\]) * No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim \[G-CSF\]) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * At least 3 weeks since prior surgery and recovered Other * Prior adjuvant or neoadjuvant therapy allowed * Prior radiosensitizers allowed * At least 2 weeks since prior gefitinib * More than 3 weeks since prior investigational agents (therapeutic or diagnostic) * No other concurrent investigational agents * No other concurrent anticancer treatment
References
Publications (0)
Data not yet available
No reference posted for this study.