Clinical trial · Interventional
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
NCT01374620CI-TRIAL-00105566PAL-ANGI2completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Paclitaxel dose escalation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel Dose escalation
- description
- 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
- interventionNames
- Drug: Paclitaxel dose escalation
- Drug: Cyclophosphamide
- Biological: Blood collection
- type
- EXPERIMENTAL
- label
- Cohort extension
- description
- An additional 10 patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose \+ blood collection
- interventionNames
- Drug: Paclitaxel
- Drug: Cyclophosphamide
- Biological: Blood collection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 clearance \> 60 ml/min (Cockcroft 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)
References
Publications (1)
- DERIVEDPannier 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. PMID 30064401