Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170625
• Other study ID #: 310300
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: March 24, 2016
• Start date: June 2004
• Est. completion date: September 2010

Study information

• Verified date: March 2016
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Compatibility of the topotecan therapy in combination with carboplatin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years

• patient with ovarian cancer after primary therapy

• bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl

• renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min

• liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range

• ECOG <= 2

• Intention of regular follow-up visits for the duration of the study

• written informed consent

Exclusion Criteria:

• any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol

• ECOG > 2

• patients with radiotherapy within the last 4 weeks

Study Design

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:
• Hycamtin
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		after each cycle	Yes
Secondary	progression-free survival		every 3 cycle	No