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Topotecan in Combination With Gemcitabine in Patients With Platinum-Resistant Ovarian Carcinoma
This study is currently recruiting participants.
Verified by Hellenic Oncology Research Group, April 2009
First Received: January 30, 2007   Last Updated: April 13, 2009   History of Changes
Sponsors and Collaborators: Hellenic Oncology Research Group
University Hospital of Crete
Information provided by: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00429559
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: Hycamptin
Drug: Gemcitabine
Phase I
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Gemcitabine Topotecan hydrochloride Gemcitabine hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-Resistant Ovarian Cancer

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan. [ Time Frame: 1year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: Hycamptin
1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
Drug: Gemcitabine

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


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429559

Contacts
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Sofia Mavraki +302810392987

Locations
Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Recruiting
Athens, Greece
Contact: George Tavoularis     +302106457968     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Aris Polyzos, MD            
"IASO" General Hospital of Athnes, Dep of Medical Oncology Recruiting
Athens, Greece
Contact: George Tavoularis     +302106457968     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Stelios Giassas, MD            
State General Hospital of Larissa, Dep of Medical Oncology Recruiting
Larissa, Greece
Contact: George Tavoularis, MD     +302106457968     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Athanasios Athanasiadis, MD            
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: George Tavoularis     +302106457968     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Ioannis Boukovinas, MD            
University General Hospital of Alexandroupolis, Dep of Medical Oncology Recruiting
Alexandroupolis, Greece
Contact: George Georgiadis     +302106457968     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Stelios Kakolyris, MD            
Greece, Crete
University Hospital of Crete Recruiting
Heraklion, Crete, Greece, 71110
Contact: Dora Hatzidaki     +302810392570     dorachat@med.uoc.gr    
Contact: Sofia Mavraki     +302810392987        
Principal Investigator: Antonia Kalikaki, MD            
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Antonia Kalikaki, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group ( A.Kalykaki )
Study ID Numbers: CT/06.14
Study First Received: January 30, 2007
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00429559     History of Changes
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Cancer;
Ovarian cancer;
Recurrent ovarian cancer platinum-resistant

Study placed in the following topic categories:
Antimetabolites
Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Immunosuppressive Agents
Antiviral Agents
Recurrence
Carcinoma
Genital Diseases, Female
Radiation-Sensitizing Agents
Ovarian Cancer
Endocrinopathy
Topotecan
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Radiation-Sensitizing Agents
Topotecan

ClinicalTrials.gov processed this record on May 07, 2009