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

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Hycamptin; Drug: Gemcitabine

• Registration Number: NCT00429559
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-30
• Study First Posted: 2007-01-31
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Hycamptin	-
A	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.	1year

Secondary Outcome Measures

Name	Time	Method
Toxicity profile	1 year

Trial Locations

Locations (6)

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"IASO" General Hospital of Athnes, Dep of Medical Oncology; 🇬🇷 Athens, Greece

State General Hospital of Larissa, Dep of Medical Oncology; 🇬🇷 Larissa, Greece