Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Conditions
Brief summary
This phase II trial is studying how well E7389 works in treating patients with recurrent or progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description
OBJECTIVES: I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer. II. Evaluate the time to progression and overall survival of patients treated with this drug. III. Evaluate the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.
Interventions
DRUGeribulin mesylate
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB or IV disease * Recurrent or progressive disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Must have received prior treatment with platinum-based therapy and a taxane * Asymptomatic brain metastasis allowed provided off steroids for \> 2 weeks * Zubrod performance status (PS) ≤ 2 OR Karnofsky PS 60-100% * Life expectancy \> 3 months * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 2.0 mg/dL * AST/ALT ≤ 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No neuropathy ≥ grade 2 * No uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would preclude study compliance * No other concurrent investigational agents * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered * At least 2 weeks since prior radiotherapy, including palliative radiotherapy, and recovered * No more than 2 prior chemotherapy regimens for NSCLC in the metastatic or adjuvant setting * No concurrent combination antiretroviral therapy for HIV-positive patients
Exclusion criteria
* Absolute neutrophil count ≥ 1,500/mm³ * No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (CR or PR) According to RECIST Criteria | Tumor measurements repeated every 6 weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From start of treatment to death from any cause, assessed up to 5 years | Will be estimated using the product-limit method of Kaplan and Meier. |
| Progression Free Survival | From start of treatment to the time of documented progression, assessed up to 5 years | Will be estimated using the product-limit method of Kaplan and Meier. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Arm I |
|---|---|
| Age, Continuous | 63 years |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 65 / 66 |
| serious Total, serious adverse events | 23 / 66 |
Outcome results
Primary
Objective Response Rate (CR or PR) According to RECIST Criteria
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: Tumor measurements repeated every 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I | Objective Response Rate (CR or PR) According to RECIST Criteria | 5 percentage of patients responding |
Secondary
Overall Survival
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame: From start of treatment to death from any cause, assessed up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I | Overall Survival | 11.6 Months |
Secondary
Progression Free Survival
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame: From start of treatment to the time of documented progression, assessed up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I | Progression Free Survival | 2.7 Months |