NCT00005055

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with saline solution may protect kidney cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of glufosfamide with or without hydration in treating patients who have advanced non-small cell lung cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2001

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

May 3, 2004

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

April 6, 2000

Last Update Submit

September 20, 2012

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

glufosfamideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Related Publications (1)

  • Giaccone G, Smit EF, de Jonge M, Dansin E, Briasoulis E, Ardizzoni A, Douillard JY, Spaeth D, Lacombe D, Baron B, Bachmann P, Fumoleau P; EORTC-New Drug Development Group. Glufosfamide administered by 1-hour infusion as a second-line treatment for advanced non-small cell lung cancer; a phase II trial of the EORTC-New Drug Development Group. Eur J Cancer. 2004 Mar;40(5):667-72. doi: 10.1016/j.ejca.2003.10.027.

    PMID: 15010066RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

beta-D-glucosylisophosphoramide mustard

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Pierre Fumoleau, MD, PhD

    Centre Georges Francois Leclerc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

May 3, 2004

Study Start

January 1, 2000

Primary Completion

March 1, 2001

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

FR(1)