Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Waggoner, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00842452
First received: February 11, 2009
Last updated: April 3, 2013
Last verified: April 2013

February 11, 2009
April 3, 2013
February 2009
April 2011   (final data collection date for primary outcome measure)
  • Maximum tolerated dose (MTD) [ Time Frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity. ] [ Designated as safety issue: Yes ]
  • Safety and tolerability [ Time Frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity. ] [ Designated as safety issue: Yes ]
  • Plasma concentration of topotecan hydrochloride when administered at the MTD [ Time Frame: blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies ] [ Designated as safety issue: No ]
  • Maximum tolerated dose (MTD) [ Designated as safety issue: Yes ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Plasma concentration of topotecan hydrochloride when administered at the MTD [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00842452 on ClinicalTrials.gov Archive Site
Response [ Time Frame: Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. ] [ Designated as safety issue: No ]
Response [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery
A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

  • To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in patients with unresectable gynecologic malignancies.
  • To determine the safety and tolerability of this drug in these patients.
  • To obtain pharmacokinetic data to assess plasma concentrations of this drug when administered at the MTD.

Secondary

  • To explore the response in patients treated with this drug.

OUTLINE: Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
  • Drug: topotecan hydrochloride
    Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Other: pharmacological study
    Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.
Experimental: Oral Topotecan
Interventions:
  • Drug: topotecan hydrochloride
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2011
April 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically* or cytologically confirmed unresectable gynecologic malignancy for which standard curative or palliative care is not available

    • All tumor types allowed NOTE: *Histologic confirmation of recurrence is not required
  • Measurable or nonmeasurable disease

    • If CT scan was used to evaluate measurable disease, lesions must be clearly defined and be ≥ 10 mm on spiral CT scan
  • No "borderline tumors" or tumors with low malignant potential

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 60 mL/min
  • AST/ALT ≤ 2.5 times ULN (< 5 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN if liver metastases are present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate intestinal function (i.e., no gastrostomy tube or requirement for IV hydration or nutritional support)
  • No severe gastrointestinal bleeding or intestinal obstruction
  • No other condition that would affect gastrointestinal absorption and motility
  • No septicemia, severe infection, or acute hepatitis
  • No other malignancies requiring chemotherapy or radiotherapy within the past 5 years, except skin cancer
  • No concurrent severe medical problem unrelated to the malignancy that would significantly limit full compliance with the study, expose the patient to extreme risk, or decrease life expectancy

PRIOR CONCURRENT THERAPY:

  • At least 28 days since prior investigational drugs (including cytotoxic drugs)
  • At least 4 weeks since prior chemotherapy, radiotherapy, biologic therapy, or surgery and recovered
  • No more than 3 prior chemotherapy regimens
  • No prior topotecan hydrochloride or other camptothecin analogs
  • No prior radiotherapy to > 25% of the bone marrow
  • No other concurrent chemotherapy, radiotherapy, biologic therapy, immunotherapy, or hormonal therapy for cancer
  • No concurrent administration of any of the following:

    • P-glycoprotein (ABCB1, Pgp, MDR1) inhibitors or inducers
    • Breast cancer-resistant protein (ABCG2, BCRP, MXR) inhibitors or inducers
  • No concurrent chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers

    • Intermittent antacid therapy is allowed provided it is given ≥ 6 hours prior to and ≥ 90 minutes after study drug administration
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00842452
CASE2Y08, P30CA043703, CASE2Y08, CASE 2Y08-CC630, NCI-2009-01290
Yes
Steven Waggoner, MD, Case Comprehensive Cancer Center
Steven Waggoner, MD
National Cancer Institute (NCI)
Principal Investigator: Stephen Waggoner, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP