Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429559
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : July 22, 2011
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Hycamptin Drug: Gemcitabine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
Study Start Date : June 2006
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: A Drug: Hycamptin
1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
Other Name: Topotecan

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

Other Name: Gemzar

Primary Outcome Measures :
  1. Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan. [ Time Frame: 1year ]

Secondary Outcome Measures :
  1. Toxicity profile [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429559

University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Antonia Kalikaki, MD University Hospital of Crete, Dep of Medical Oncology

Responsible Party: A.Kalykaki, Hellenic Oncology Research Group Identifier: NCT00429559     History of Changes
Other Study ID Numbers: CT/06.14
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

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

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