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Home > "G" Clinical Trials Conditions > Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small cell Lung Cancer  Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small cell Lung Cancer
Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3A non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PierreFumoleau, Study Chair, EORTC Early Clinical Studies Group
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Additional Information:
Study ID Numbers: CDR0000067650; EORTC-16994N,ASTA-D-19575-3167
Study Start Date: January 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005055
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
2. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
3. T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
4. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
5. Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small cell Lung Cancer
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