Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2006-09-12
2007-08-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All treated subjects
All subjects received Topotecan, administered intravenously over 30 minutes at 4 milligrams per meter\^2 weekly for 3 weeks every 28 days.
topotecan
topotecan
Interventions
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topotecan
topotecan
Eligibility Criteria
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Inclusion Criteria
* Performance status of 0, 1, or 2 on the Eastern Co-operative Oncology Group (ECOG) Scale
* Predicted life expectancy of at least 3 months
* Subjects with histologically or cytologically confirmed advanced solid tumors who have failed conventional therapy for their tumor type or have a tumor type for which no standard effective therapy exists; OR Patients for whom single-agent topotecan therapy is suitable
* At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery
* Must be free of post-treatment side effects (with the exception of alopecia)
* No concurrent chemotherapy, biologic therapy or radiotherapy is allowed
* Hemoglobin = 9.0 g/dL
* WBC = 3,500/mm3 \[= 3.5 x 109/L\]
* Neutrophils = 1,500/mm3 \[= 1.5 x 109/L\]
* Platelets = 100,000/mm3 \[= 100.0 x 109/L\]
* Calculated creatinine clearance=60 mL/min using the Cockcroft-Gault formula
* Serum bilirubin \< 2.0 mg/dL (34 µmol/L) AST, SGPT/ALT and alkaline phosphatase \< 2 times the upper limit of normal if liver metastases cannot be visualized by abdominal computed tomography (CT) or magnetic resonance imaging (MRI scan)
* If liver metastases are present, subjects with \< 5 times the upper limit of normal are eligible to participate
Exclusion Criteria
* Women subjects of childbearing potential who refuse to abstain from sexual intercourse or practice adequate contraception. Childbearing potential is defined as women who are not surgically sterilized (i.e. have not had a hysterectomy, bilateral oophorectomy \[ovariectomy\], or bilateral tubal ligation) or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study).
* Men unwilling to abstain from sex or use effective contraception during the study and for 3 months following completion of topotecan treatment
* Subjects with uncontrolled emesis, regardless of etiology
* Active infection
* Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
* Treatment with another investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer)
* History of allergic reactions to compounds chemically related to topotecan.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Scottsdale, Arizona, United States
Countries
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References
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Kurtis, KK, Jewell RC, Hartney JT, Griffin, PP, et al. Phase I study to characterize pharmacokinetics (PK) of topotecan (T) at 4 mg/m2 administered weekly as a 30-minute IV infusion. J Clin Oncol 26: 2008 (May 20 suppl; abstr 13551).
Other Identifiers
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HYT104152
Identifier Type: -
Identifier Source: org_study_id