Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Hycamptin
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Cancer;, Ovarian cancer;, Recurrent ovarian cancer platinum-resistant
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed ovarian adenocarcinoma
- Patients had to have received a front-line, platinum- based chemotherapy regimen
- Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy
- Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125
- A >= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
- Age > 18 years old
- Performance status (WHO) 0-2
- Life expectancy of at least three months
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl)
- Informed consent
Exclusion Criteria:
- Pregnant or nursing
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Sites / Locations
- University Hospital of Crete
- University General Hospital of Alexandroupolis, Dep of Medical Oncology
- "IASO" General Hospital of Athnes, Dep of Medical Oncology
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
- State General Hospital of Larissa, Dep of Medical Oncology
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.
Secondary Outcome Measures
Toxicity profile
Full Information
NCT ID
NCT00429559
First Posted
January 30, 2007
Last Updated
July 21, 2011
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
1. Study Identification
Unique Protocol Identification Number
NCT00429559
Brief Title
Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
Official Title
Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
4. Oversight
5. Study Description
Brief Summary
Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly in patients with platinum -resistant ovarian cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Cancer;, Ovarian cancer;, Recurrent ovarian cancer platinum-resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hycamptin
Other Intervention Name(s)
Topotecan
Intervention Description
1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks.
Number of cycles: until progression
Primary Outcome Measure Information:
Title
Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.
Time Frame
1year
Secondary Outcome Measure Information:
Title
Toxicity profile
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed ovarian adenocarcinoma
Patients had to have received a front-line, platinum- based chemotherapy regimen
Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy
Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125
A >= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
Age > 18 years old
Performance status (WHO) 0-2
Life expectancy of at least three months
Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl)
Informed consent
Exclusion Criteria:
Pregnant or nursing
Psychiatric illness or social situation that would preclude study compliance
Other concurrent uncontrolled illness
Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia Kalikaki, MD
Organizational Affiliation
University Hospital of Crete, Dep of Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athnes, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
We'll reach out to this number within 24 hrs