Clinical trial · Interventional
Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
NCT00054197CI-TRIAL-00047485terminatedPhase 3ClinicalTrials.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. Combining more than one drug may kill more tumor cells. It is not yet known whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of gemcitabine or vinorelbine in treating patients who have stage IIIB, stage IV, or recurrent 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel poliglumex | Drug | — | UNRESOLVED |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
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 (NSCLC) meeting 1 of the following criteria: * Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery * Stage IIIB and not a candidate for combined modality therapy * Stage IV * No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology * Cytological diagnosis must be based on the following: * No cellular diagnosis by sputum cytology alone * Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable * Measurable or nonmeasurable disease * Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met: * Neurologic function stable for at least 2 weeks before study entry * Off steroid therapy or on a tapering regimen * Recovered from prior therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin) Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No unstable angina * No myocardial infarction within the past 6 months * Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry Neurologic * See Disease Characteristics * No neuropathy greater than grade 1 * No evidence of unstable neurologic symptoms within the past 4 weeks (2 weeks for neurologic symptoms due to brain metastases) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide) * No clinically significant active infection * No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer * No other unstable medical conditions * No circumstance that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No prior systemic biologic agent for lung cancer Chemotherapy * See Disease Characteristics * No prior systemic chemotherapy for lung cancer including radiosensitizing agents Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * No concurrent radiotherapy Surgery * See Disease Characteristics * Recovered from prior major surgery Other * More than 12 weeks since prior participation in any research study or treatment with investigational drugs * Recovered from prior investigational therapy or stable for 4 weeks before study treatment * No other concurrent investigational drugs * No other concurrent systemic antitumor therapy * No concurrent amifostine * Concurrent bisphosphonates allowed
References
Publications (1)
- RESULTO'Brien ME, Socinski MA, Popovich AY, Bondarenko IN, Tomova A, Bilynsky BT, Hotko YS, Ganul VL, Kostinsky IY, Eisenfeld AJ, Sandalic L, Oldham FB, Bandstra B, Sandler AB, Singer JW. Randomized phase III trial comparing single-agent paclitaxel Poliglumex (CT-2103, PPX) with single-agent gemcitabine or vinorelbine for the treatment of PS 2 patients with chemotherapy-naive advanced non-small cell lung cancer. J Thorac Oncol. 2008 Jul;3(7):728-34. doi: 10.1097/JTO.0b013e31817c6b68. PMID 18594318