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Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00100932
First received: January 7, 2005
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another chemotherapy.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
Drug: E7389 28 Day Cycle
Drug: E7389 21 Day Cycle
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of E7389, a Halichondrin B Analog, in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC), Who Progressed During or After Platinum-Based Doublet Chemotherapy Stratified for Prior Taxane Therapy

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Overall Objective Response Rate (ORR) [ Time Frame: From start of treatment until disease progression or recurrence ] [ Designated as safety issue: No ]
    Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).


Secondary Outcome Measures:
  • Duration of Response [ Time Frame: From time of CR or PR until recurrence or progressive disease ] [ Designated as safety issue: No ]
    Measured from the time that measurement criteria were met for complete response (CR) and partial response (PR) until the first date that recurrence or progressive disease was objectively documented.

  • Progression Free Survival [ Time Frame: From start of study medication until progressive disease or death ] [ Designated as safety issue: No ]
    Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.

  • Overall Survival [ Time Frame: From time of start of study medication until death ] [ Designated as safety issue: No ]
    Defined as the time from the start of study medication until death from any cause.


Enrollment: 106
Study Start Date: December 2004
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
E7389 28 day cycle
Drug: E7389 28 Day Cycle
E7389 1.4 mg/m^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle.
Experimental: 2
E7389 21 day cycle
Drug: E7389 21 Day Cycle
E7389 1.4 mg/m^2 IV bolus on Days 1 and 8 of a 21 day cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Patients must have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer with at least one site of measurable disease by the RECIST criteria.
  • Patients must have failed prior platinum-containing doublet chemotherapy. Patients who have received single agent chemotherapy with or without a subsequent taxane containing regimen may be enrolled after discussion with Sponsor.
  • Patients must be ≥ 18 years of age.
  • Patients must have a performance score of 0 or 1 using the ECOG performance scale.
  • Patients must have a life expectancy of ≥ 3 months.
  • Patients must have adequate renal function as evidenced by a serum creatinine ≤ 2.0 mg/dL or a calculated creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault formula.
  • Patients must have adequate hepatic function as evidenced by bilirubin ≤1.5 mg/dL and alkaline phosphatase, AST and ALT ≤ 3 times upper limit of normal, unless there is evidence of liver metastases, in which case the alkaline phosphatase, AST and ALT must be ≤ 5 times upper limit of normal.
  • Patients must have adequate bone marrow function as evidenced by absolute neutrophil counts (ANC) ≥ 1.5 X 10^9/L, hemoglobin ≥ 10.0 g/dL (a hemoglobin < 10.0 g/dL would be acceptable if it can be corrected by growth factor or transfusion), and platelet count ≥ 100 X 10^9/L.
  • Patients must be willing and able to comply with the protocol guidelines for the duration of the study.
  • Patients must be willing and able to complete the Lung Cancer Symptom Scale (LCSS) instrument.
  • The biopsy specimen (paraffin block or at least 10 unstained slides) must be available from either the initial diagnosis or any subsequent diagnostic or surgical procedure of patients participating in the pharmacogenomics sub-study only. However, no additional biopsies are obligatory for participation in this study except those required for confirmation of the diagnosis.
  • Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

EXCLUSION CRITERIA:

  • Patients with pre-existing peripheral neuropathy > Grade 2
  • Patients who require therapeutic doses of warfarin
  • Patients who have not recovered from any chemotherapy, radiation or other therapy related toxicity deemed to be clinically significant at study entry
  • Patients with active symptomatic brain metastases. Patients with central nervous system (CNS) metastases are considered eligible if they have had adequately treated brain metastases, i.e. have completed treatment (tapered off steroids) at least four weeks before starting treatment with E7389. Patients who have no evidence that the metastases are symptomatic or actively growing (no evidence of midline shift on CT scan or MRI) may be enrolled without initiation of local therapy for the CNS metastases. In this case, a repeat scan must be performed within four weeks of the original scan to ensure that disease progression is not occurring. It is not the intention of this study to treat patients with active brain metastases.
  • Patients who have a positive history for HIV, active hepatitis B or active hepatitis C.
  • Patients with other significant medical, or psychiatric disorders that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
  • Patients who have received investigational drugs, including immunotherapy, gene therapy, hormone therapy (except megestrol acetate for appetite stimulation), or other biological therapy; conventional chemotherapy or radiation therapy (except for palliation, defined as less than 10% of the bone marrow reserve and less than 20 Gy), within three weeks of E7839 enrollment
  • Patients who have received non-cytotoxics (eg, gefitinib, erlotinib) within one week of E7389 enrollment
  • Patients who have not recovered from major surgery within three weeks of E7389 enrollment
  • Patients with severe/uncontrolled intercurrent illness/infection
  • Patients with significant cardiovascular impairment (history of congestive heart failure>NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
  • Patients with organ allografts
  • Patients with hypersensitivity to halichondrin B and/or halichondrin B-related compounds
  • Patients who participated in a prior E7389 clinical trial
  • Patients with second malignancy within the past 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • Women who are pregnant or breast-feeding; woman of childbearing potential with a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months or using adequate contraception to be considered of non-childbearing potential.
  • Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100932

Locations
United States, California
Gilroy, California, United States
United States, Florida
Ocala, Florida, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Missouri
Columbia, Missouri, United States
St. Joseph, Missouri, United States
St. Louis, Missouri, United States
United States, Nebraska
McCook, Nebraska, United States
United States, Ohio
Canton, Ohio, United States
United States, Texas
Dallas, Texas, United States
Fort Worth, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Norfolk, Virginia, United States
United States, Washington
Vancouver, Washington, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Dale Shuster, Ph.D. Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00100932     History of Changes
Other Study ID Numbers: E7389-A001-202
Study First Received: January 7, 2005
Results First Received: December 26, 2011
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014