[2000]-[BNP7787]-[Phase 1 Trial]
Record 1
Phase I Study of Dimesna in Patients with Solid Tumor Undergoing Treatment with Cisplatin and Paclitaxel (Summary Last Modified 06/2000)
Protocol IDs: BIONUM-BNP7787IV101, NCI-G98-1478, RPCI-DS-9739
Protocol Type: supportive care, treatment
Sponsorship: NCI-sponsored, NCI-sponsored trial in cancer center, pharmaceutical
Status: Active
Age Range: 18 and over
OBJECTIVES
I. Determine the maximum tolerated dose (MTD) of dimesna administered prior to
cisplatin and paclitaxel in patients with solid tumors.
II. Determine the dose related qualitative and quantitative side effects of
dimesna administered on this schedule in these patients.
III. Determine the minimum safe volume of intravenous hydration after the
determination of the MTD of dimesna in these patients.
IV. 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.
V. Investigate the pharmacokinetic behavior of dimesna in the plasma and urine
on this schedule of administration in this patient population.
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)
--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
--Patient Characteristics--
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
At least 6 weeks
Hematopoietic:
WBC greater than 4,000/mm3
Absolute neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3
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
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.
STRATIFICATION
Not abstracted
SPECIAL STUDY PARAMETERS
Not abstracted
END POINTS
Not abstracted
PROJECTED ACCRUAL
Approximately 35 patients will be accrued into this study.
WARNING
The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening for or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The
therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more
effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
DOSAGE SCHEDULE
Not abstracted
DOSAGE FORMS
Not abstracted
PARTICIPATING ORGANIZATIONS/STUDY CONTACTS
Patrick J. Creaven, Chair Ph: 716-845-8451Roswell Park Cancer Institute
STUDY CONTACTS
U.S.A.
Illinois
Richard L. Schilsky, Ph: 773-834-3914University of Chicago Cancer Research CenterChicago, Illinois, U.S.A.
Maryland
Ross C. Donehower, Ph: 410-955-8838Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland, U.S.A.
New York
Patrick J. Creaven, Ph: 716-845-8451Roswell Park Cancer InstituteBuffalo, New York, U.S.A.
cancer.gov |
