Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Paclitaxel

Criteria

Inclusion Criteria:

• Patient with cancer histologically proved

• No other therapeutic proposal after discussion in multidisciplinary consultation

• Radiological evidence of the evolving nature of the disease

• Measurable disease with at least one measurable lesion according to the criteria RECIST 1.1

• At least 28 days since prior treatment(systemic treatment or major surgery)

• Patient who have recovered from any previous toxicity

• Man or woman de ≥ 18 years and ≤ 65 years

• Performance Status (ECOG) ≤ 2 within 7 days before inclusion

• Polynuclear neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hemoglobin ≥ 9 g/dl

• Serum Albumin ≥ 36 g/l and lymphocytes ≥ 700/mm3

• Total bilirubin and SGPT/ALT and SGOT/AST ≤ 3 ULN(≤ 5 ULN if liver metastases)

• Creatinine in normal ranges and Creatinine clairance > 60 ml/min (Cockroft formulae)

• Central venous access

• Negative pregnancy test for women who may be pregnant within 7 days before inclusion

• Effective contraceptive during the treatment period and up to 6 months after the end of treatment (for patients of both sexes during their reproductive and child-bearing age and their partners)

• Patient covered by government health insurance

• Informed consent signed by the patient before any specific study procedure

Exclusion Criteria:

• Prior treatment by Paclitaxel

• Oral treatment impossible

• Known dysphagia, malabsorption or maldigestion

• Pre-existing neuropathy clinically symptomatic

• Known leptomeningeal brain metastases

• Known allergy to Cremophor, to Paclitaxel or one of its excipients (especially polyoxyethylene castor oil), to Cyclophosphamide or one of its excipients (lactose, sucrose)

• Active and uncontrolled infection

• Acute urinary tract infection, pre-existing hemorrhagic cystitis

• Diabetes insipidus

• History or progressive psychiatric illness

• Persons under guardianship or detainees

• Unable for medical follow-up (geographic, social or mental reasons)

• Pregnant, or likely to be or breastfeeding women

• Absence of effective contraception for the duration of treatment and 6 months after completion of therapy (for patients of both sexes in childbearing or reproductive age and their partners)