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

Ovarian Cancer Clinical Trial

Official title:

Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429559
• Other study ID #: CT/06.14
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 30, 2007
• Last updated: July 21, 2011
• Start date: June 2006
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Hycamptin
1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
• 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

Locations

Country	Name	City	State
Greece	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	University Hospital of Crete	Heraklion	Crete
Greece	State General Hospital of Larissa, Dep of Medical Oncology	Larissa
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.		1year	Yes
Secondary	Toxicity profile		1 year	Yes