Clinical trial · Interventional
Cabazitaxel - PF Induction Chemotherapy
Phase I Study of Cabazitaxel - Platinum Fluorouracil Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
NCT01379339CI-TRIAL-00016838completedPhase 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 primary objective of this study is to determine the first-cycle maximum tolerated dose (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck for three cycles.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel 10mg/m2 | Drug | Cabazitaxel | ALIAS |
| Cabazitaxel 12.5mg/m2 | Drug | Cabazitaxel | ALIAS |
| Cabazitaxel 15mg/m2 | Drug | Cabazitaxel | ALIAS |
| Cabazitaxel 17.5mg/m2 | Drug | Cabazitaxel | ALIAS |
| Cabazitaxel 20mg/m2 | Drug | Cabazitaxel | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cabazitaxel 10mg/m2
- description
- * Cabazitaxel on D1 Dose: 10mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)
- interventionNames
- Drug: Cabazitaxel 10mg/m2
- type
- EXPERIMENTAL
- label
- Cabazitaxel 12.5mg/m2
- description
- * Cabazitaxel on D1 Dose: 12.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with stage IV only, previously untreated, locally advanced SCCHN (patients may have had previous surgery, but not chemotherapy or radiotherapy). * During the dose escalation phase before the MTD and DLT are established for cabazitaxel combined with cisplatin and FU induction chemotherapy primary sites allowed include the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, and unknown primary regardless of Human Papilloma Virus (HPV) status. Metastatic SCCHN will be allowed in escalation phase. * Once MTD and DLT for cabazitaxel combined with cisplatin and FU induction chemotherapy are established (expansion cohort) primary sites allowed include the oral cavity, oropharynx (HPV negative only), larynx, hypopharynx, nasopharynx, and unknown primary (HPV negative only). No patients with metastases will be allowed in this phase (expansion cohort). * Age \>/= 18 years * Eastern Cooperative Oncology Group PS 0-1 * Predicted life expectancy \>/= 12 weeks * Absolute Neutrophilic Count (ANC) \>/= 1.5 x 10\^9/L, Platelets \>/= 100 x 10\^9/L; bilirubin \</= 1.5 x Upper Limit of Normal (ULN), Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) \</= 2.5 x ULN or \</= 5 x ULN if patient has documented liver metastases; serum creatinine \</= 1.5 x ULN * Patients in the expansion cohorts must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) * Patients must be accessible for repeat dosing and follow-up * Patients - both males and females - with reproductive potential must agree to practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test at baseline and on Day 1 * Patients must provide verbal and written informed consent to participate in the study Exclusion Criteria: * Locally advanced HPV positive oropharyngeal or unknown primary SCCHN for the expansion cohort only (Once MTD and DLT for cabazitaxel combined with cisplatin and FU induction chemotherapy established). * History of significant cardiac disease unless the disease is well-controlled * Grade 2 peripheral neuropathy * No excessive alcohol consumption will be allowed * Serious comorbid illness, and involuntary weight loss of more than 20% of body weight in the 3 months preceding study entry * History of cerebrovascular accident (CVA) within 12 months prior to registration or that is not stable * History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent * Pregnant or breast-feeding females Gastrointestinal (GI) abnormalities including inability to take oral medication, requirement for IV alimentation, active peptic ulcer, or prior surgical procedures affecting absorption * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug * Any type of active seizure disorder * Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing * Use of strong or moderate CYP3A4 or CYP1A2 inhibitors/inducers, with the exception of low-dose steroids, within 14 days prior to Day 1 dosing * Symptomatic brain metastases that are not stable, require steroids, or that have required radiation within the last 28 days * Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study * History of Hepatitis C or Human Immunodeficiency Virus (HIV) infection, autoimmune disease, or major organ transplant. * Surgery, irradiation or chemotherapy within the previous 4 weeks * Any other concomitant anticancer therapies * Patients will be excluded if they received any prior chemotherapy, radiotherapy, or treatment with biologic response modifiers (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) * History of colitis or chronic diarrheal illness * History of, or active, co-morbid medical condition, which in the opinion of the investigator, would raise significant risk to the patient.
References
Publications (26)
- BACKGROUNDForastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, Glisson B, Trotti A, Ridge JA, Chao C, Peters G, Lee DJ, Leaf A, Ensley J, Cooper J. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003 Nov 27;349(22):2091-8. doi: 10.1056/NEJMoa031317. PMID 14645636
- BACKGROUNDAdelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008. PMID 12506176
- BACKGROUNDDomenge C, Hill C, Lefebvre JL, De Raucourt D, Rhein B, Wibault P, Marandas P, Coche-Dequeant B, Stromboni-Luboinski M, Sancho-Garnier H, Luboinski B; French Groupe d'Etude des Tumeurs de la Tete et du Cou (GETTEC). Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. French Groupe d'Etude des Tumeurs de la Tete et du Cou (GETTEC). Br J Cancer. 2000 Dec;83(12):1594-8. doi: 10.1054/bjoc.2000.1512. PMID 11189100
- BACKGROUNDPosner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956. PMID 17960013
- BACKGROUNDJordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer. 2004 Apr;4(4):253-65. doi: 10.1038/nrc1317. No abstract available. PMID 15057285
- BACKGROUNDMita AC, Denis LJ, Rowinsky EK, Debono JS, Goetz AD, Ochoa L, Forouzesh B, Beeram M, Patnaik A, Molpus K, Semiond D, Besenval M, Tolcher AW. Phase I and pharmacokinetic study of XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors. Clin Cancer Res. 2009 Jan 15;15(2):723-30. doi: 10.1158/1078-0432.CCR-08-0596.