Lung CancerPhase 2NCT00005055
Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing glufosfamide in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- glufosfamide
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2000to Mar 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Non Small Cell Lung Cancer
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- glufosfamide
- Keywords
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glufosfamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startJan 2000
- Primary completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Fumoleau, MD, PhD, Study chair, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005055
- Sponsor's protocol ID
- EORTC-16994N
- Other IDs
- EORTC-16994N, ASTA-D-19575-3167
- Status last verified
- Sep 2012
- First submitted
- 6 Apr 2000
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
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.
PubMed 15010066
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00005055
- Acronym / sponsor ID
- EORTC-16994N
- Conditions
- Lung Cancer
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jan 2000
- Primary completion
- Mar 2001 (actual)
- First posted
- 3 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glufosfamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 15010066Giaccone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Fumoleau, MD, PhD study chair
Centre Georges Francois Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glufosfamide in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.