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Home > "D" Clinical Trials Conditions > Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel  Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel
Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel
For Condition: Head and Neck Cancer,neurotoxicity,female reproductive cancer,thorax and respiratory cancer
Status: Completed
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as dimesna may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of dimesna in treating patients with solid tumors who are undergoing treatment with cisplatin and paclitaxel.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of dimesna administered prior to cisplatin and paclitaxel in patients with solid tumors. - Determine the dose related qualitative and quantitative side effects of dimesna administered on this schedule in these patients. - Determine the minimum safe volume of intravenous hydration after the determination of the MTD of dimesna in these patients. - Investigate the possible protective side effects of dimesna in reducing or preventing the development of cisplatin induced nephrotoxicity and observe possible protective effects against cisplatin or paclitaxel related neurotoxicity and myelosuppression in these patients. - Investigate the pharmacokinetic behavior of dimesna in the plasma and urine on this schedule of administration in this patient population. OUTLINE: This is a dose-escalation, two-stage, multicenter study. During stage I, patients receive a single dose of dimesna IV over 15 minutes 7 days prior to chemotherapy. Patients then receive paclitaxel IV over 3 hours followed by dimesna IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour on day 1 every 3 weeks. Patients continue courses of paclitaxel, dimesna, and cisplatin every 3 weeks in the absence of disease progression or unacceptable toxicity for up to 6 courses. In stage I, cohorts of 3-6 patients each receive escalating doses of dimesna until the maximum tolerated dose (MTD) is reached. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT). The MTD of dimesna is then used in stage II of the study, in which the volume of pre and post cisplatin intravenous saline hydration is reduced in cohorts of 3-6 patients each. The MTD intensity of cisplatin is defined as the least saline hydration volume at which no more than 1 of 6 patients experience DLT. PROJECTED ACCRUAL: Approximately 35 patients will be accrued into this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer, ovarian carcinoma, squamous cell carcinoma of the head and neck, tumor types for which no standard treatment exists, or tumor types that have failed standard therapy - Paclitaxel and cisplatin combination therapy must be an appropriate option in treating disease - No potentially curable type of cancer (e.g., newly diagnosed testicular cancer) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 6 weeks Hematopoietic: - WBC greater than 4,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin normal - SGOT and SGPT normal Renal: - Creatinine normal - Creatinine clearance at least 60 mL/min Cardiovascular: - No evidence of congestive heart failure - No uncontrolled moderate to severe hypertension - Includes patients with persistent elevated systolic blood pressures of greater than 170 mm Hg and diastolic blood pressures of greater than 100 mm Hg for more than 1 month while under medical treatment Other: - No active infection - No perceived or actual clinical risk of cisplatin induced toxicity that exceeds the clinical benefit of using cisplatin therapy - No known history of severe hypersensitivity to polyoxyl 35 castor oil vehicle - No severe medical problems unrelated to malignancy that would interfere with compliance in this study - Not pregnant - Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent colony stimulating factors except for febrile neutropenia - No concurrent aminoglycoside therapy except for febrile neutropenia or other life threatening infections - No concurrent immunotherapy Chemotherapy: - At least 6 weeks since prior nitrosoureas or mitomycin - At least 3 weeks since other prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to measurable disease Surgery: - At least 2 weeks since prior major surgery Other: - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickCreaven, Study Chair, Roswell Park Cancer Institute
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000066635; RPCI-DS-9739,BIONUM-BNP7787IV101,NCI-G98-1478
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003569
Other Head And Neck Cancer Studies:
1. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
2. PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
3. Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
4. Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel
5. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Related Studies:
Other Head and Neck Cancer Clinical Trials
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Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel
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