A Phase 2 interventional study of Paclitaxel and Quality-of-Life Assessment in Recurrent Non-Small Cell Lung Carcinoma and Stage IV Non-Small Cell Lung Cancer, sponsored by University of Nebraska. Completed at 5 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment
This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES: I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. II. To assess the response rate of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. III. To assess the quality of life of elderly patients with advanced non-small cell lung cancer during administration of weekly paclitaxel and vinorelbine. OUTLINE: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 20 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
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Exclusion Criteria:
Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Drug: Paclitaxel · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Drug: Vinorelbine Tartrate
Given IV
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Given IV
Also known as: Biovelbin, Eunades, KW-2307, Navelbine, Navelbine Ditartrate, Vinorelbine Ditartrate
Progression-free Survival.
Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions.
Time frame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.
Time frame: Up to week 17
Response Rate Based on RECIST Criteria
The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Time frame: Up to 5 years
| Milestone | Treatment |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions.
| Months | Treatment Group |
|---|---|
| Progression-free Survival. | 7.8 (1.92 to 13.56) |
Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.
| Participants | Treatment |
|---|---|
| Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events | 6 |
The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
| Participants | Treatment Group |
|---|---|
| Response Rate Based on RECIST Criteria | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Vinorelbine Tartrate, Paclitaxel) | 16/20 (80%) | 6/19 (31.6%) | 19/19 (100%) |
| Event | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|
| Febrile neutropeniaInfections and infestations | 2/19 |
| Cardiac arrestCardiac disorders | 1/19 |
| Ischemic encephalopathyNervous system disorders | 1/19 |
| Acute hypoxic respiratory failureRespiratory, thoracic and mediastinal disorders | 1/19 |
| pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 1/19 |
| Event | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|
| LeukopeniaBlood and lymphatic system disorders | 5/19 |
| pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 5/19 |
| hypoxemiaRespiratory, thoracic and mediastinal disorders | 5/19 |
| AnemiaBlood and lymphatic system disorders | 4/19 |
| NeutropeniaBlood and lymphatic system disorders | 4/19 |
| back painMusculoskeletal and connective tissue disorders | 2/19 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/19 |
| LymphopeniaBlood and lymphatic system disorders | 1/19 |
| Febrile neutropeniaInfections and infestations | 1/19 |
| AnorexiaMetabolism and nutrition disorders | 1/19 |
| Age, Customized(years) | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|
| Mean | 76.9 ± 3.6 |
| Sex: Female, Male(Participants) | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|
| Female | 4 |
| Male | 16 |
| Race and Ethnicity Not Collected(Participants) | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|
| Region of Enrollment(Participants) | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|
| United States | 20 |
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Paclitaxel · Vinorelbine
Carcinoma, Non-Small-Cell Lung →