Topotecan Pharmacokinetic Characterization Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00361803
First received: August 7, 2006
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Malignancy
Solid Tumor Cancer
Cancer
Drug: topotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Characterize the Pharmacokinetics of Topotecan at 4 mg/m2 Administered Weekly as a 30-Minute Intravenous Infusion in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • CL and Vss of total topotecan

Secondary Outcome Measures:
  • Cmax tmax t½ AUC(0-t) AUC(0-8) of total topotecan. Safety and tolerability will also be evaluated.

Estimated Enrollment: 15
Study Start Date: September 2006
Intervention Details:
    Drug: topotecan
    Other Name: topotecan
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361803

Locations
United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
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).

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00361803     History of Changes
Other Study ID Numbers: HYT104152
Study First Received: August 7, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
chemotherapy
recurrent
refractory
research
cancer
pharmacokinetics

Additional relevant MeSH terms:
Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014