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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Small Cell Lung

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gerold Bepler, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

TH-CR-304

NCT ID:

NCT00435578

Start Date:

February 2007

Completion Date:

November 2007

Related Keywords:

  • Carcinoma, Small Cell Lung
  • Recurrent Sensitive Small-Cell Lung Cancer
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
California Cancer CenterFresno, California  93720
Karmanos Cancer InstituteDetroit, Michigan  48201