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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00429559
• Date of registration: 30/01/2007
• Prospective Registration: No
• Primary sponsor: Hellenic Oncology Research Group
• Public title: Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
• Scientific title: Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
• Date of first enrolment: June 2006
• Target sample size: 31
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00429559
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Greece

Contacts

• Name: Antonia Kalikaki, MD
• Affiliation: University Hospital of Crete, Dep of Medical Oncology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Drug: Hycamptin

Drug: Gemcitabine

Primary Outcome(s)

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

Secondary Outcome(s)

Toxicity profile [Time Frame: 1 year]

Secondary ID(s)

CT/06.14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of Crete