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Oral Topotecan to Treat Recurrent or Persistent Solid Tumors
This study is currently recruiting participants.
Verified by Accelerated Community Oncology Research Network, April 2009
First Received: September 27, 2006   Last Updated: April 17, 2009   History of Changes
Sponsors and Collaborators: Accelerated Community Oncology Research Network
GlaxoSmithKline
Information provided by: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00382733
  Purpose

The purpose of this study is to evaluate the effectiveness of oral topotecan and how well the chemotherapy is tolerated (any side effects) when it is given in different dose levels. The study will also collect information on how the medication is being broken down and absorbed in the body and how quality of life is affected during treatment.


Condition Intervention Phase
Tumors
Drug: Oral Topotecan
Phase I
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Topotecan hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: Oral Topotecan, Utilization for a Metronomic Dosing Schedule to Treat Recurrent or Persistent Solid Tumors

Further study details as provided by Accelerated Community Oncology Research Network:

Primary Outcome Measures:
  • The primary endpoint is to determine the recommended phase II metronomic dose of topotecan, with the upper dose limit set at grade II toxicity. [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary endpoints are: the tolerability profile [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • response rates [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • pharmacokinetic parameters [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • biomarker evaluations (TSP-1, CEPC, VEGF, Topo-1, HIF-1, CD31 vessel counts) [ Time Frame: Every 4-8 weeks depending on the biomarker ] [ Designated as safety issue: No ]
  • and tumor marker responses. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: November 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oral Topotecan
    Topotecan will be recieved in one of the five dose levels 0.25mg,0.5mg, 0.75mg, 1.0mg, and 1.25mg. Dose escalation phase of the trial has been concluded. The maximum tolerated dose was determined to be 1.0mg of oral topotecan administered daily.
  Eligibility

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

Inclusion Criteria:

  • Patient provides written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • Male or female patients.
  • Patient is at least 18 years of age with recurrent or persistent solid tumors.
  • Patient has adequate hematologic function (absolute neutrophil count [ANC] >= 1500/mL and platelets >= 100,000/mL), adequate renal function (serum creatinine < 2.0 mg/dL; calculated creatinine clearance > 40 mL/min), and adequate hepatic function (serum bilirubin <= 1.5 mg/dL and transaminases <= 3 times the upper limit of normal [3 x ULN]).
  • Patient has Eastern Oncology Cooperative Group (ECOG) performance status of <= 2.
  • Patient has a life expectancy of at least 3 months at time of enrollment.
  • Patient has no medical problems, unrelated to the malignancy, of sufficient severity which would limit full compliance with the study or which would expose him/her to undue risks.
  • Patient has received no more than 2 prior treatment regimens prior to enrollment including chemotherapy, hormonal therapy, biologic therapy, and immunotherapy.
  • Patient has a negative serum or urine pregnancy test within 7 days prior to starting therapy (if a female of childbearing potential).

Exclusion Criteria:

  • Patient is a pregnant or lactating woman. Women of childbearing potential with either a positive or no pregnant test (serum or urine) at baseline.

Women of childbearing potential not using a reliable and appropriate contraceptive method will be excluded. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Patients must agree to continue contraception for 30 days from the date of the last study drug administration.

  • Patient has serious, uncontrolled, concurrent infection(s).
  • Patient has received whole pelvic or extended field radiation therapy within 4 weeks of enrollment. Patients who have not fully recovered or whose acute toxicity related to prior radiotherapy has not returned to baseline are ineligible.
  • Patient has received myelosuppressive chemotherapy within the last 4 weeks or has not recovered from the myelosuppressive effects of recent chemotherapy.
  • Patient has received another investigational agent within 4 weeks prior to study enrollment.
  • Patient has known hypersensitivity to topoisomerase I inhibitors.
  • Patient is unable to swallow a capsule or has a disease known to affect drug absorption, such as short gut syndrome or active radiation enteritis.
  • Patient has received drugs known to alter absorption such as antacids, proton pump blockers (eg, omeprazole), or H2 receptor antagonists (eg, cimetidine). A washout period of one week (7 days) is required prior to initiating study medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382733

Contacts
Contact: Mandy Johns, RHIA, CCRP 901-435-5578 ext 1527 ajohns@sosacorn.com
Contact: Cindy Lee, RN, MSN,CCRP 901-259-8282 clee@sosacorn.com

Locations
United States, Tennessee
The West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Todd Tillmanns, M.D.            
Sponsors and Collaborators
Accelerated Community Oncology Research Network
GlaxoSmithKline
Investigators
Principal Investigator: Todd D. Tillmanns, M.D. West Clinic
  More Information

No publications provided

Responsible Party: Accelerated Community Oncology Research Network ( Amanda Johns, RHIA, CCRP )
Study ID Numbers: ACORN ATDTROC0501
Study First Received: September 27, 2006
Last Updated: April 17, 2009
ClinicalTrials.gov Identifier: NCT00382733     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Accelerated Community Oncology Research Network:
Solid Tumors

Study placed in the following topic categories:
Topotecan
Recurrence

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

ClinicalTrials.gov processed this record on May 07, 2009