Clinical trial · Interventional
Bortezomib and Pemetrexed Disodium in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
Phase I/II Study of Two Different Schedules of Bortezomib (VELCADE, PS-341) and Pemetrexed (ALIMTA) in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer (NSCLC)
- 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: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed disodium may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of bortezomib when given together with pemetrexed disodium and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors.
Conditions
Conditions (2)
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 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Number of Patients Experiencing a Dose-limiting Toxicity (Phase I)
- timeFrame
- Up to 36 months
- description
- Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion or lasting \>7 days; febrile neutropenia; grade 3 neutropenia associated with infection; any other grade \>/=3 non-hematologic toxicity considered by the investigator to be related to study drug.
- measure
- Number of Participants Who Experience Adverse Events (Phase I)
- timeFrame
- Throughout the entire study (up to 36 months).
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 (Phase I).
- measure
- Number of Patients With Grade ≥ 3 Toxicity (Phase I)
- timeFrame
- First cycle of treatment (3 weeks)
- description
- Grade 3/4 toxicity occurring in a patient within 1 cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Cytologically or histologically confirmed diagnosis of 1 of the following:
* Advanced solid tumor that progressed after standard therapy or for which no effective curative therapy exists (phase I)
* Stage IIIB (pleural effusion) or IV non-small cell lung cancer (NSCLC) (phase II)
* Disease must have progressed or recurred after 1 platinum-based therapy regimen
* NSCLC that has progressed or recurred after first-line therapy for stage IIIA or IIIB disease allowed
* Measurable disease
* Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiotherapy
* Evaluable disease (bone metastases, pleural fluid, ascites) allowed (phase I)
* No symptomatic brain metastasis or disease requiring steroids and anticonvulsants
* Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastases allowed provided patient is neurologically stable and has been off steroids and anticonvulsants for ≥ 4 weeks
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2 (phase I) or 0-1 (phase II)
* Life expectancy ≥ 3 months
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
* Bilirubin normal
* AST ≤ 2.5 times upper limit of normal
* Granulocyte count ≥ 1,500/mm³
* Platelet count of ≥ 100,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No pre-existing neuropathy ≥ grade 2
* No other prior malignancy except for the following (phase II):
* Adequately treated basal cell or squamous cell skin cancer
* In situ cervical cancer
* Adequately treated stage I or II cancer currently in complete remission
* Any other cancer from which the patient has been disease free for \> 5 years
* No hypersensitivity to bortezomib, boron, or mannitol
* No cardiovascular complications, including any of the following:
* Myocardial infarction within the past 6 months
* New York Heart Association class III-IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities
* Any ECG abnormality at screening must be documented as not medically relevant
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior bortezomib or pemetrexed disodium
* Any number of prior chemotherapy regimens allowed (phase I)
* More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C) and recovered
* More than 2 weeks since prior radiotherapy and recovered
* No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2 days prior and 2 days after (5 days pre and post for long-acting NSAIDs) administration of pemetrexed disodium
* No concurrent anticonvulsants that are metabolized by the cytochrome P450 pathwayReferences
Publications (1)
- RESULTDavies AM, Ho C, Metzger AS, Beckett LA, Christensen S, Tanaka M, Lara PN, Lau DH, Gandara DR. Phase I study of two different schedules of bortezomib and pemetrexed in advanced solid tumors with emphasis on non-small cell lung cancer. J Thorac Oncol. 2007 Dec;2(12):1112-6. doi: 10.1097/JTO.0b013e31815ba7d0. PMID 18090584