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E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

eribulin mesylate

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope
University of Pittsburgh Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival

Will be estimated using the product-limit method of Kaplan and Meier.

Progression Free Survival

Will be estimated using the product-limit method of Kaplan and Meier.

Full Information

NCT ID

NCT00400829

First Posted

November 16, 2006

Last Updated

December 23, 2014

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00400829

Brief Title

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

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

eribulin mesylate

Other Intervention Name(s)

B1939, E7389, ER-086526, halichrondrin B analog

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Objective Response Rate (CR or PR) According to RECIST Criteria

Description

Time Frame

Tumor measurements repeated every 6 weeks

Secondary Outcome Measure Information:

Title

Overall Survival

Description

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

Title

Progression Free Survival

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Gitlitz

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

University of Pittsburgh Cancer Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

12. IPD Sharing Statement

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E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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