Clinical trial · Interventional
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
NCT00064012CI-TRIAL-00042236completedPhase 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 docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB 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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Velcade Alone
- description
- Velcade
- interventionNames
- Drug: bortezomib
- type
- EXPERIMENTAL
- label
- Velcade plus Docetaxel
- description
- Velcade plus Docetaxel
- interventionNames
- Drug: bortezomib
- Drug: docetaxel
Primary outcomes (0)
[]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 * Locally advanced (stage IIIB) or metastatic (stage IV) disease * Inoperable disease * Relapsed or refractory disease * Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease * Measurable or evaluable disease * No symptomatic or inadequately treated brain metastases * No CNS disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic * AST and ALT less than 3 times upper limit of normal (ULN) * Bilirubin less than 1.5 times ULN * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine less than 1.8 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No electrocardiographic evidence of acute ischemia or active conduction system abnormalities * No poorly controlled hypertension Immunologic * No active systemic infection requiring treatment * No prior allergic reaction attributable to compounds containing boron or mannitol * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No peripheral neuropathy grade 2 or greater * No diabetes mellitus * No other serious medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 6 weeks since prior monoclonal antibody therapy * No concurrent routine use of colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy * No prior docetaxel * Prior paclitaxel allowed * No other concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery * No concurrent surgery for cancer management or treatment Other * More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix * More than 4 weeks since prior investigational agents * No prior bortezomib * No other concurrent investigational agents * No other concurrent clinical research study participation * No other concurrent antineoplastic therapy * No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)
References
Publications (1)
- RESULTFanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, Govindan R, Raez LE, Robert F, Ribeiro M, Akerley W, Kelly K, Limentani SA, Crawford J, Reimers HJ, Axelrod R, Kashala O, Sheng S, Schiller JH. Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5025-33. doi: 10.1200/JCO.2006.06.1853. PMID 17075122