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Sponsors and Collaborators: |
Hellenic Oncology Research Group University Hospital of Crete |
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Information provided by: | Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00429559 |
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 |
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Ovarian Cancer |
Drug: Hycamptin Drug: Gemcitabine |
Phase I Phase II |
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 |
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 |
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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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Sofia Mavraki | +302810392987 |
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 |
Principal Investigator: | Antonia Kalikaki, MD | University Hospital of Crete, Dep of Medical Oncology |
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 |
Cancer; Ovarian cancer; Recurrent ovarian cancer platinum-resistant |
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 |
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 |