Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy
A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this regimen. This will form the basis for future studies comparing this combination to what is now considered standard regimen for first line therapy in patients with NSCLC, carboplatin, paclitaxel and bevacizumab.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 4 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 1, 2019 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of Massachusetts, Worcester
- Interventions being studied
- Drug: Bortezomib 1.3 mg/m2; Drug: Bortezomib 1.6 mg/m2; Drug: Bortezomib 1.8 mg/m2; Drug: Carboplatin AUC 6; Drug: Bevacizumab; Drug: Taxotere
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically confirmed SCLC (adeno- and large cell, anaplastic carcinoma and broncho-alveolar-carcinoma). Patients with squamous-cell histology are eligible with extra thoracic or peripheral lung lesions only.
- Sputum cytology alone not acceptable evidence of cell type. Cytologic specimens obtained by brushing, washings, or needle aspiration of defined lesions will be acceptable. Mixed tumors will be categorized by the predominant cell type unless a small cell anaplastic elements are present, in which case the patient is ineligible.
- Stage III B because of pleural effusion or Stage IV disease
- Measurable disease.
- Age: 18 years or older
- No history of thrombotic, hemorrhagic, or coagulopathy disorders
- international normalized ratio (INR\<1.5) and a prothrombin time (PTT) no greater than normal limits of normal within 1 week prior to registration. NB: subjects with lung cancer placed on anticoagulant therapy for a thrombotic event are not eligible for this study.
- No gross hemoptysis (defined as bright red blood of ½ teaspoon or more)
- No central nervous system (CNS) or brain metastasis
- Laboratory Criteria (completed \<2 weeks before enrollment):
- Hematologic: white blood cell (WBC) \> 3500/mm3 or absolute neutrophil count (ANC) \> 1500/mm3 and platelet count \> 100 000/ mm3;
- Hepatic: Total bilirubin \< 1.5 mg/dl
- Renal: Creatinine \< 1.5 mg/dl. or calculated
- Creatinine clearance \> 45 ml/min (NB: Urine protein:creatinine ratio in
- )
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2
- Be free of active infection.
- Be available for active follow up.
- No prior chemotherapy for metastatic disease.
- Be disease free for \> 5 years if they had a prior second malignancy other than treated basal cell carcinoma or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Female subject post-menopausal; surgically sterilized or willing to use an acceptable method of birth control for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Massachusetts Medical SchoolWorcester, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 1, 2019. Always confirm current availability with the study team.