Clinical efficacy and cell mobilization activity of pegfilgrastim in patients with gynaecological malignancies in therapy with topotecan. - ND
- Conditions
- MedDRA version: 9.1Level: HLGTClassification code 10038594Term: Reproductive neoplasms female malignant and unspecifiedovarian cancer, cervical cancer, endometrial cancer
- Registration Number
- EUCTR2007-006069-34-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Patients with advanced gynaecological malignancies who undergo salvage-chemotherapy with topotecan and prophylaxis of febrile neutropenia with GCSF according to the NCCN-2005 guidelines (6) are enrolled in the present study. In particular, the following patient populations are administered with standard-dose topotecan: i) ovarian cancer patients with disease progression after 1st line chemotherapy (carboplatin and taxol) followed by 2nd and 3rd line treatments (i.e. antracyclines). ii) endometrial or cervical cancer patients, eventually treated with radiotherapy, with disease progression after 2 lines of chemotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
leucemy, AML Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method