Trial Outcomes & Findings for Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00602797)

Last Updated: 2023-09-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years

Results posted on

2023-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
Overall Study Adverse Event	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Vinorelbine Tartrate, Paclitaxel) n=20 Participants Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Vinorelbine Tartrate: Given IV
Age, Customized	76.9 years STANDARD_DEVIATION 3.6 • n=20 Participants
Sex: Female, Male Female	4 Participants n=20 Participants
Sex: Female, Male Male	16 Participants n=20 Participants
Region of Enrollment United States	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants Patients \>70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
Progression-free Survival.	7.8 Months Interval 1.92 to 13.56

SECONDARY outcome

Timeframe: Up to week 17

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=20 Participants Patients \>70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events	6 Participants

SECONDARY outcome

Timeframe: Up to 5 years

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

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants Patients \>70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
Response Rate Based on RECIST Criteria	5 Participants

Adverse Events

Treatment (Vinorelbine Tartrate, Paclitaxel)

Serious events: 6 serious events

Other events: 19 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Vinorelbine Tartrate, Paclitaxel) n=19 participants at risk Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Vinorelbine Tartrate: Given IV
Infections and infestations Febrile neutropenia	10.5% 2/19 • Number of events 2 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Cardiac disorders Cardiac arrest	5.3% 1/19 • Number of events 1 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Nervous system disorders Ischemic encephalopathy	5.3% 1/19 • Number of events 1 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Respiratory, thoracic and mediastinal disorders Acute hypoxic respiratory failure	5.3% 1/19 • Number of events 1 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Respiratory, thoracic and mediastinal disorders pulmonary infiltrates	5.3% 1/19 • Number of events 1 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.

Other adverse events

Other adverse events
Measure	Treatment (Vinorelbine Tartrate, Paclitaxel) n=19 participants at risk Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Vinorelbine Tartrate: Given IV
Blood and lymphatic system disorders Anemia	21.1% 4/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Blood and lymphatic system disorders Neutropenia	21.1% 4/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Blood and lymphatic system disorders Leukopenia	26.3% 5/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Blood and lymphatic system disorders Lymphopenia	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Respiratory, thoracic and mediastinal disorders pulmonary infiltrates	26.3% 5/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Infections and infestations Febrile neutropenia	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Respiratory, thoracic and mediastinal disorders hypoxemia	26.3% 5/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Musculoskeletal and connective tissue disorders back pain	10.5% 2/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Metabolism and nutrition disorders Anorexia	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Endocrine disorders Hyperglycemia	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.5% 2/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
General disorders weakness	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
General disorders fatigue	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Respiratory, thoracic and mediastinal disorders Bronchospasm	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Gastrointestinal disorders Bowel perforation	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Metabolism and nutrition disorders Hypocalcemia	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Metabolism and nutrition disorders Hyponatremia	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Metabolism and nutrition disorders Weight loss	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
Immune system disorders Allergic reaction	5.3% 1/19 All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.

Additional Information

Apar Ganti

University of Nebraska Medical Center

Phone: 402-559-5622

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place