Topotecan Pharmacokinetic Characterization Study

Cancer Clinical Trial

Official title:

A Phase I Study to Characterize the Pharmacokinetics of 4 mg/m2 Weekly Intravenous Topotecan in Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361803
• Other study ID #: HYT104152
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2006
• Last updated: November 13, 2017
• Start date: September 12, 2006
• Est. completion date: August 9, 2007

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 9, 2007
• Est. primary completion date: August 9, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Written informed consent

• 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 who are pregnant or lactating

• 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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• topotecan
topotecan

Locations

Country	Name	City	State
United States	GSK Investigational Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CL and Vss of total topotecan		Predose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.5, 4.5, 6.5, 8.5, 12, and 24 hours after the start of infusion on Day 1
Secondary	Cmax tmax t½ AUC(0-t) AUC(0-8) of total topotecan. Safety and tolerability will also be evaluated.		Up to 77 days

External Links

•   Results for study HYT104152 can be found on the GSK Clinical Study Register.