Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Non Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Non Small Cell Lung Cancer


OBJECTIVES: I. Determine the activity of glufosfamide as determined by objective response in
patients with non-small cell lung cancer. II. Determine the response rate in this patient
population after this treatment. III. Determine the duration of objective response in these
patients treated with this drug. IV. Characterize the toxicities of this drug in these
patients. V. Assess the impact of the hydration scheme on the toxicity profile (renal
function) of this drug in these patients. VI. Assess the pharmacokinetic profile of this
drug in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to
receive glufosfamide with or without hydration. Arm I: Patients receive glufosfamide IV over
1 hour every 3 weeks. Arm II: Patients receive glufosfamide as in arm I. Patients are
hydrated with excess physiological saline solution 4 hours before and 3 hours after
treatment with glufosfamide. Treatment in both arms continues for 2-6 courses in the absence
of unacceptable toxicity or disease progression. Patients with an objective complete
response continue treatment for a maximum of 2 courses after the confirmation of response.
Patients are followed every 6 weeks until disease progression.

PROJECTED ACCRUAL: A total of 16-32 patients (8-16 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer not amenable to curative surgery or radiotherapy Metastatic or inoperable locally
advanced progressive disease At least 1 target lesion accurately measurable in at least 1
dimension Longest diameter at least 20 mm with conventional techniques or at least 10 mm
with spiral CT scans Must have failed and completed 1 and only 1 platinum based regimen in
the first line setting for metastatic/inoperable locally advanced disease No symptomatic
brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases
present) SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal: Creatinine no greater than 1.7 mg/dL Creatinine clearance at least 60 mL/min
Cardiovascular: Clinically normal cardiac function No history of ischemic heart disease No
congestive heart failure within the past 6 months Normal 12 lead ECG Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception No
other prior or concurrent malignancies except cone biopsied carcinoma of the cervix or
adequately treated basal or squamous cell skin carcinoma No unstable systemic diseases No
active uncontrolled infections No psychological, familial, sociological, or geographical
condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF)
No concurrent prophylactic growth factors Chemotherapy: See Disease Characteristics At
least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At
least 4 weeks since prior radiotherapy Concurrent radiotherapy allowed provided not all
target lesions are in irradiated field Surgery: At least 14 days since prior major surgery
Other: No other concurrent anticancer agents No other concurrent investigational therapy
No concurrent prophylactic antiemetics during course 1

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Pierre Fumoleau, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Authority:

United States: Federal Government

Study ID:

EORTC-16994N

NCT ID:

NCT00005055

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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