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Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel (PAL-ANGI2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374620
First Posted: June 16, 2011
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Oscar Lambret
June 14, 2011
June 16, 2011
July 29, 2016
June 2011
February 2013   (Final data collection date for primary outcome measure)
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 ]

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

Same as current
Complete list of historical versions of study NCT01374620 on ClinicalTrials.gov Archive Site
  • Description of the nature of adverse events [ Time Frame: During the study treatment, an expected average of 2 months ]
    According to the NCI-CTCAE scale v4.0
  • Evaluation of objective response after 2 cycles [ Time Frame: After 2 cycles = 2 months ]
    Objective response (complete response, partial response and stable disease) according to RECIST 1.1 criteria
  • Estimation of the free-progression median time [ Time Frame: Until disease progression ]
    Time between the inclusion and the disease progression (clinical or radiological)
  • Calculation of the Growth Modulation Index (GMI) [ Time Frame: Until disease progression ]
    Time to progression on study treatment and time to progression on prior treatment
  • Evaluation of the correlation between clinical response and biological parameters [ Time Frame: Day 1, 8, 15, 21 of cycle 1 and cycle 2 ]
    Biological parameters related to angiogenesis
  • Description of the severity of adverse events [ Time Frame: During the study treatment, an expected average of 2 months ]
    According to the NCI-CTCAE scale v4.0
Same as current
Not Provided
Not Provided
 
Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel
Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide
The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.
The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide for cancer which present no therapeutic solution
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
  • Drug: Paclitaxel dose escalation

    Paclitaxel will be administered intravenously over 60 minutes, at D1, D8 and D15, at a given dose.

    The Paclitaxel dose (mg/infusion) levels are as follows:

    • 40
    • 60
    • 70
    • 75
    • 80
    • 85
    • 90
    Other Name: Taxol
  • Drug: Paclitaxel
    Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide
    Other Name: Taxol
  • Drug: Cyclophosphamide

    D1 to D28: 50 mg x 2/day/cycle

    1 cycle = 28 days

    Other Name: Endoxan
  • Biological: Blood collection
    At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters
  • Experimental: Paclitaxel Dose escalation

    A standard dose escalation strategy will be used including 3 to 6 patients at each dose level (Paclitaxel dose escalation + fixed dose of cyclophosphamide)

    + blood collection

    Interventions:
    • Drug: Paclitaxel dose escalation
    • Drug: Cyclophosphamide
    • Biological: Blood collection
  • Experimental: Cohort extension

    An additional 10 patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose

    + blood collection

    Interventions:
    • Drug: Paclitaxel
    • Drug: Cyclophosphamide
    • Biological: Blood collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2013
February 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01374620
PAL-ANGI2
Yes
Not Provided
Plan to Share IPD: No
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: Nicolas PENEL, MD Centre Oscar Lambret
Centre Oscar Lambret
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP