Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Time Frame:

after each cycle

Safety Issue:

Yes

Principal Investigator

Jalid Sehouli

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Virchow Klinikum

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

310300

NCT ID:

NCT00170625

Start Date:

June 2004

Completion Date:

September 2010

Related Keywords:

  • Ovarian Cancer
  • platin-resistant
  • Ovarian Neoplasms

Name

Location