Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel
NCT ID: NCT01374620
Last Updated: 2016-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2011-06-30
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
NCT00420563
Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin
NCT00611962
17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor
NCT00087217
Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
NCT00077129
Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
NCT00004173
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
Cyclophosphamide
D1 to D28: 50 mg x 2/day/cycle
1 cycle = 28 days
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
Cohort extension
An additional 10 patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose
\+ blood collection
Paclitaxel
Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide
Cyclophosphamide
D1 to D28: 50 mg x 2/day/cycle
1 cycle = 28 days
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Paclitaxel
Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide
Cyclophosphamide
D1 to D28: 50 mg x 2/day/cycle
1 cycle = 28 days
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Oscar Lambret
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicolas PENEL, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Oscar Lambret
Lille, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pannier D, Adenis A, Bogart E, Dansin E, Clisant-Delaine S, Decoupigny E, Lesoin A, Amela E, Ducornet S, Meurant JP, Le Deley MC, Penel N. Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial. BMC Cancer. 2018 Jul 31;18(1):775. doi: 10.1186/s12885-018-4678-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PAL-ANGI2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.