SR-45023A in Treating Patients With Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT00003822 |
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Recruitment Status : Unknown
Verified March 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 21, 2004
Last Update Posted : July 24, 2008
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have advanced solid tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Drug: apomine | Phase 1 |
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors that are refractory or for which no standard therapy exists. II. Determine the quantitative toxic effects of SR-45023A in these patients. III. Assess the pharmacokinetic profile of SR-45023A in these patients. IV. Identify the antitumor activity of SR-45023A in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A twice daily for 14 days, followed by 7 days rest. On day 14 of course 1, patients receive only one dose of therapy due to pharmacokinetic sampling. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed until death.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I and Pharmacokinetic Study of SR-45023A During a 14-Day Treatment Schedule |
| Study Start Date : | August 1998 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic or solid tumors refractory to standard therapy or for which no standard therapy exists (surgery, radiotherapy, and/or chemotherapy) Measurable or evaluable disease by medical photograph, plain x-ray, CT, MRI, palpation, or serum tumor markers at least 2 times upper limit of normal No asymptomatic brain metastases No leukemia, lymphoma, or multiple myeloma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL No coagulation disorders Hepatic: Bilirubin normal AST and ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) Renal: Creatinine less than 1.5 mg/dL Creatinine clearance at least 45 mL/min Cardiovascular: No cardiac conduction abnormalities Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No concurrent serious systemic disorders No concurrent or recent (within past 6 months) small bowel obstruction, symptoms of small bowel obstruction, or any other gastrointestinal disease
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent filgrastim (G-CSF) Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior SR-45023A No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal cancer therapy (except contraception, hormone replacement therapy, and corticosteroids) Radiotherapy: See Disease Characteristics Prior radiotherapy allowed to less than 25% of the bone marrow and recovered No prior radiotherapy to the whole pelvis No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational agents No other concurrent investigational agents No concurrent anticoagulation therapy (e.g., Coumadin or heparin) No concurrent digoxin, beta blockers, or calcium channel blockers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003822
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| Study Chair: | Susan Smith | Genzyme, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00003822 History of Changes |
| Other Study ID Numbers: |
CDR0000066975 ILEX-SR101-A9 ILEX-SR101 UARIZ-HSC-98161 NCI-V99-1532 |
| First Posted: | May 21, 2004 Key Record Dates |
| Last Update Posted: | July 24, 2008 |
| Last Verified: | March 2001 |
Keywords provided by National Cancer Institute (NCI):
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unspecified adult solid tumor, protocol specific |