Phase 2
Completed N=48
Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer · Stage IIIA Non-small Cell Lung Cancer · Stage IIIB Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00093756 ↗
Enrolled (actual)
48
Serious AEs
43.8%
Results posted
Dec 2014
Primary outcomePrimary: The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only. — 0.73 proportion of Participants
Summary
This phase I/II trial (phase I closed to accrual as of 09/29/2009) is studying the side effects and best dose of bortezomib, paclitaxel, and carboplatin when given with radiation therapy and to see how well they work in treating patients with stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of paclitaxel and carboplatin by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving bortezomib, paclitaxel, and carboplatin together with radiation therapy may kill more tumor cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only. |
0.73 | — |
| SECONDARY Confirmed Tumor Response |
3; 4 | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Progression-free Survival |
8.4 | — |
| SECONDARY Overall Survival |
25 | — |
| SECONDARY Frequency and Severity of Observed Toxicity, Graded by Common Terminology Criteria for Adverse Events (CTCAE) |
22; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Locally advanced stage IIIA or IIIB disease that is considered unresectable
- No stage IV disease
- Requires radiotherapy
- Performance status (PS) - Eastern Cooperative Oncology Group (ECOG) 0-1
- At least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Forced expiratory volume (FEV) FEV\_1 ≥ 1 L OR 35% of predicted
- Weight loss < 10% within the past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neuropathy ≥ grade 2
- No other severe underlying disease that would preclude study participation
- No uncontrolled infection
- No unhealed wound within the past 2 weeks
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- No prior systemic chemotherapy for NSCLC*
- No prior radiotherapy to the chest
- More than 2 weeks since prior major surgery
Contraindications
- Any of the following:
- Pregnant wome
- Nursing women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) as this regimen may be harmful to a developing fetus or nursing child NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
- Any of the following prior therapies:
- Prior radiation therapy to the chest
- Prior systemic chemotherapy for NSCLC (phase II portion)
- New York Heart Association classification III or IV (see Appendix II).
- Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study.
- uncontrolled infection.
- Major surgery or unhealed wound ≤ 2 weeks prior to registration.
- Prior history of malignancy ≤ 5 years, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer.
- Peripheral neuropathy ≥grade 2
Data sourced from ClinicalTrials.gov (NCT00093756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.