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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT01374620
• Date of registration: 14/06/2011
• Prospective Registration: No
• Primary sponsor: Centre Oscar Lambret
• Public title: Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel PAL-ANGI2
• Scientific title: Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide
• Date of first enrolment: June 2011
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01374620
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Nicolas PENEL, MD
• Affiliation: Centre Oscar Lambret

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Biological: Blood collection

Drug: Cyclophosphamide

Drug: Paclitaxel

Drug: Paclitaxel dose escalation

Primary Outcome(s)

Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide [Time Frame: 28 days = cycle 1]

Secondary Outcome(s)

Estimation of the free-progression median time [Time Frame: Until disease progression]

Evaluation of objective response after 2 cycles [Time Frame: After 2 cycles = 2 months]

Description of the severity of adverse events [Time Frame: During the study treatment, an expected average of 2 months]

Evaluation of the correlation between clinical response and biological parameters [Time Frame: Day 1, 8, 15, 21 of cycle 1 and cycle 2]

Calculation of the Growth Modulation Index (GMI) [Time Frame: Until disease progression]

Description of the nature of adverse events [Time Frame: During the study treatment, an expected average of 2 months]

Secondary ID(s)

PAL-ANGI2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors