ovarian cancer, cervical cancer, endometrial cancer MedDRA version: 9.1 Level: HLGT Classification code 10038594 Term: Reproductive neoplasms female malignant and unspecified
Conditions
Interventions
Trade Name: HYCAMTIN
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Topotecan
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Conc
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: leucemy, AML Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: nd;Primary end point(s): i) mobilization of different cell populations in peripheral blood (i.e. peripheral blood progenitor cells, mesenchymal cells, dendritic cells, T-reg lymphocytes). ii) serum levels of different cytokines (IFNγ, IL8, IL4, IL12p70, IL2, IL6, IL5, HGF, IL10, TNFα, IL1β). iii) haematological toxicity (sec. WHO);Main Objective: The aims of the present study protocol are at two levels: i) biological level: study of the cell mobilization capacity and cytokine modulation activity induced by standard treatment with pegfilgrastim after chemotherapy in cancer patients. ii) clinical level: study of the protection from febrile neutropenia induced by prophylaxis with pegfilgrastim in patient with cancer who undergo chemotherapy with topotecan. | — |
Countries
Italy
Outcome results
None listed