Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPaclitaxel
Given IV
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
DRUGVinorelbine Tartrate
Given IV
Sponsors
National Cancer Institute (NCI)
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically proven non-small cell lung cancer with evidence of distant metastases/malignant pleural effusion * Measurable disease on imaging studies in 2 dimensions * No previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the past five years * Patients who have had a previous resection for their lung cancer and present with recurrent disease will be eligible * Patients with other prior malignancies will be included, provided they have been disease-free for at least five years * Patients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated carcinoma in-situ of the cervix and hormone sensitive prostate cancer will be eligible * Karnofsky score \>= 70 (Eastern Cooperative Oncology Group \[ECOG\] 0-2) * White blood cell (WBC) count \>= 3,500/mm\^3, OR * Absolute neutrophil count (ANC) \>= 1,500/ul * Platelet count \>= 100,000/mm\^3 * Serum creatinine less than 1.5 times the upper limits of normal * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.5 times the upper limits of normal * Serum alkaline phosphatase less than 2.5 times the upper limits of normal * No active serious infections or other condition precluding chemotherapy * Non-pregnant and non-nursing * Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on the study * Able to give informed consent * Able to return for treatment and follow-up as specified in the protocol
Exclusion criteria
* Known hypersensitivity to any component of vinorelbine or paclitaxel or other required drugs in the study * Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol * Inability to fulfill the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival. | Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events | 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. |
| Response Rate Based on RECIST Criteria | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Vinorelbine Tartrate, Paclitaxel) 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Treatment (Vinorelbine Tartrate, Paclitaxel) | — |
|---|---|---|
| Age, Customized | 76.9 years STANDARD_DEVIATION 3.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 Participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 20 |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 6 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Progression-free Survival. | 7.8 Months |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events | 6 Participants |
Comparison: Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Response Rate Based on RECIST Criteria | 5 Participants |