Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma

Sponsor

Threshold Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00435578

Collaborator

(none)

Enrollment

Locations

Duration (Months)

16.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this study are:

To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate
To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC

The secondary objectives are:

To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival
To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)

The exploratory objectives of this trial are:

To evaluate the effect of glufosfamide on lung cancer symptoms
To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Small Cell Lung	Drug: Glufosfamide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 18 years of age
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/IEC
Documented extensive SCLC with progression occurring at least 60 days after completion of first-line therapy (sensitive disease)
Measurable disease by RECIST criteria (at least one target lesion; no target lesion may have received radiotherapy within 6 weeks of study start)
A minimum of 21 days between prior radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
Recovered from reversible toxicities of prior therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,500/µL, platelets ≥ 100,000/µL
Total bilirubin ≤ 1.5-fold ULN
AST/ALT ≤ 2.5-fold ULN (≤ 5-fold ULN if liver metastases)
Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose

Exclusion Criteria:

More than one previous chemotherapy regimen
Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for SCLC other than protocol therapy
Limited stage SCLC (defined as confined to one hemithorax including ipsilateral supraclavicular lymph nodes and excluding pleural effusion)
Symptomatic brain metastases requiring corticosteroids
Active clinically significant infection requiring antibiotics
Known HIV positive or active hepatitis B or C
Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, congestive heart failure, or stroke
Other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
Major surgery within 28 days of the start of study treatment, without complete recovery
Females who are pregnant or breast-feeding
Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
Concomitant disease or condition that could interfere with the conduct of the study, or that, in the opinion of the investigator, could pose an unacceptable risk to the subject in this study.
Unwillingness or inability to comply with the study protocol for any other reason

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Cancer Center	Greenbrae	California	United States	94904
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
3	Karmanos Cancer Institute	Detroit	Michigan	United States	48201

Sponsors and Collaborators

Threshold Pharmaceuticals

Investigators

Principal Investigator: Gerold Bepler, MD, PhD, H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: John C Ruckdeschel, MD, Barbara Ann Karmanos Cancer Institute
Principal Investigator: Peter D Eisenberg, MD, California Cancer Center