Document Detail


Phase I-II study of dose intensified chemotherapy with filgrastim and thymopentin in patients with advanced cancer.
MedLine Citation:
PMID:  9377855     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Carboplatin (CBDCA), cyclophosphamide (CTX) and etoposide (VP-16) combination chemotherapy is active in many tumors. A phase I-II study was designed in order to verify toxicity, maximum tolerated dose and activity of CBDCA, CTX and VP-16 given with Granulocyte Colony Stimulating Factor (G-CSF) and thymopentin (TP5), without bone marrow support. MATERIALS AND METHODS: A group of 12 heavily pretreated patients (PTS), 9 breast cancer, 2 small cell lung cancer and 1 gastric cancer, received fourteen courses of the described combination chemotherapy. Previous treatments were as follows: surgery in 10 PTS, radiotherapy in 7 PTS, chemotherapy in all PTS (median of 9 courses per patient). CBDCA, CTX, VP-16 were given over 3 days. CBDCA doses were calculated and expressed with the area under the concentration versus time curve (AUC). The dose range were as follows: CBDCA AUC 5.5-11 (400-800 mg/m2), CTX 1500-2500 mg/m2, VP-16 450-550 mg/m2, G-CSF was given 5 mg/kg/day from day 4 to day 17. TP5 was given, on alternate days, 1 mg/ kg from day 4 to day 30. RESULTS: 6 PTS developed fever > 38 degrees C for a median (M) duration of 4 days. 4 PTS required platelet support (M of 12 units) and 3 PTS red blood cells support (M of 2 units). Maximum tolerated dose was CBDCA AUC of 8, CTX 2000 mg/m2 and VP16500 mg/m2. No treatment related death occurred. Ten patients had responses and two had disease stabilisation. At the present time 5 PTS are alive and median overall survival is 13 months. CONCLUSIONS: These data indicate that dose intensified CT with the support of G-CSF and TP5 may be delivered safely and shows activity in heavily pre-treated patients.
Authors:
F Recchia; S De Filippis; L Ginaldi; D Quaglino; A Gulino; L Frati; S Rea
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  La Clinica terapeutica     Volume:  148     ISSN:  0009-9074     ISO Abbreviation:  Clin Ter     Publication Date:    1997 May-Jun
Date Detail:
Created Date:  1997-11-12     Completed Date:  1997-11-12     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0372604     Medline TA:  Clin Ter     Country:  ITALY    
Other Details:
Languages:  eng     Pagination:  201-7     Citation Subset:  IM    
Affiliation:
Division of Internal Medicine (Oncology Unit), Civil Hospital Avezzano, Rome.
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MeSH Terms
Descriptor/Qualifier:
Breast Neoplasms / drug therapy*,  pathology
Carcinoma, Small Cell / drug therapy*,  pathology
Dose-Response Relationship, Drug
Eligibility Determination
Female
Filgrastim / administration & dosage,  therapeutic use*
Humans
Lung Neoplasms / drug therapy*,  pathology
Neoplasm Staging
Palliative Care*
Stomach Neoplasms / drug therapy*,  pathology
Survival Rate
Thymopentin / administration & dosage,  therapeutic use*
Chemical
Reg. No./Substance:
121181-53-1/Filgrastim; 69558-55-0/Thymopentin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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