Clinical trial NCT00400829: E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official title: A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-11-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (CR or PR) According to RECIST Criteria
timeFrame: Tumor measurements repeated every 6 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: From start of treatment to death from any cause, assessed up to 5 years
measure: Progression Free Survival
timeFrame: From start of treatment to the time of documented progression, assessed up to 5 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
Study officials:
affiliation: City of Hope Medical Center
name: Barbara Gitlitz
role: PRINCIPAL_INVESTIGATOR
References: