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

Thank you

Trial Information


Inclusion Criteria:



- Patients ≥ 18 years of age

- recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and
paclitaxel were eligible to this trial.

- Eastern Cooperative Oncology Group (ECOG) performance status less than 3.

- renal function (serum creatinine 1.25 times the upper limit of normal, glomerular
filtration rate greater than 60 ml/min)

- liver function (AST/ ALT three times the upper limit of normal, bilirubin
concentrations 1.25 the upper limit of normal)

- bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count
greater than 100 x 109/l).

Exclusion Criteria:

- patients with more than 4 chemotherapies in medical history

- severe cardiac disease

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:

Toxicity

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:

32005000

NCT ID:

NCT00170573

Start Date:

October 2001

Completion Date:

August 2010

Related Keywords:

  • Ovarian Cancer
  • biweekly schedule of PLD - Ovarian cancer - pegylated liposomal doxorubicin -quality of life - Toxic skin reactions
  • Ovarian Neoplasms

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