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Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide

Phase 1
18 Years
65 Years
Open (Enrolling)

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Trial Information

Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide

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

- 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,

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide

Outcome Description:

A DLT is defined below: Hematological toxicity: Polunuclear neutrophils < 500/mm3 for more than 7 days Febrile neutropenia (Polunuclear neutrophils < 1 000/mm3 and fever > or = 38.5°C) or documented infection Thrombopenia (Platelets < 25 000/mm3) Impossibility to administer D8 or D15 due to hematological critera Non-hematological toxicity: Any grade 3 or 4 toxicity related to study treatment, with the exception of fatigue and alopecia

Outcome Time Frame:

28 days = cycle 1

Safety Issue:


Principal Investigator

Nicolas PENEL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2011

Completion Date:

December 2014

Related Keywords:

  • Cancer
  • Cancer