TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer

NCT01108042 | Completed Phase 1 DMC

• 2 other identifiers: TISOC-12009-011902-41
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 4

Brief Summary

A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks. In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will be defined. In the phase II-part the progression-free survival after 2 years will be assessed in patients treated with the optimal therapeutic dose.

Conditions

Oropharynx Cancer; Squamous Cell Carcinoma of the Oral Cavity

Outcome Measures

Primary Outcomes (1)

• Determination of progression-free survival after 2 years

  24 months

Secondary Outcomes (5)

• Overall survival after 2 years

  after 2 years

• Determination of the efficacy of the induction therapy

  after 1, 12 and 24 months

• Function of swallowing according the penetration-aspiration-scale

  0,1, 6, 12, 18, 24 months

• Adverse events as a measure of safety and tolerability

  once a week

• Quality of life

  0,1, 6, 12, 18, 24 months

Study Arms (1)

Taxotere, Cisplatin, 5-Fluorouracil (5-FU)

EXPERIMENTAL

Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out.

Drug: Taxotere, Cisplatin, 5-Fluorouracil (5-FU)

Interventions

Taxotere, Cisplatin, 5-Fluorouracil (5-FU) DRUG

Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out. Phase 2: Optimal dose of phase 1 will be given.

Also known as: Docetaxel

Taxotere, Cisplatin, 5-Fluorouracil (5-FU)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological proven, resectable squamous epithelial carcinoma of the oropharynx and the cavity of the mouth
• R0-resection possible
• All T N2 M0 / all T N3 M0 / if T3 or T4a also N0-1 M0
• Leucocytes \> 4000/mm³ bzw. neutrophils \> 2000/mm³, thrombocytes \> 100000/mm³
• adequate kidney function, defined as serum creatinine und urea in normal range, Creatinine clearance \> 60 ml/min
• adequate liver function with glutamate oxaloacetate transaminase (SGOT), glutamate pyruvate transaminase (SGPT) and bilirubin in normal range
• electrolytes in normal range
• risks of anesthesia complications normal or minor increased
• Eastern Cooperative Oncology Group (ECOG) 0-2 / Karnofsky \>= 60%
• Age 18 - 80 years
• signed written informed consent
• effective contraception for both male and female subjects if the risk of conception exists

You may not qualify if:

• T1 N0 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0
• Resection without curative intention: primary tumor is not treatable with resection methods
• Infiltration of the lower jaw
• M1 status
• Tumor not measurable with Innovation Center Computer Assisted Surgery (ICCAS) methods
• No prior chemotherapy or radiation (a primary surgery is allowed)
• Metachronous or oder synchronous malignoma (Exception: basal cell carcinoma)
• Life expectance \< 3 months
• ECOG \> 2; Karnofsky \< 60%
• acute infections or fever
• known HIV-infection or other immune suppression
• severe cardio pulmonary concomitant diseases
• chronic disease with continuous therapy (uncontrolled diabetes, rheumatoid arthritis) especially continuous therapy with steroids
• other concomitant diseases which, in the investigator's opinion, would exclude the patient from the study
• Contraindications which permit a therapy with Docetaxel, Cisplatin, 5-FU or radiation therapy

Sponsors & Collaborators

• Orlando Guntinas-Lichius, Prof. Dr. med.: lead

Study Sites (4)

Städt. Kliniken Bielefeld gem. GmbH

Bielefeld, 33604, Germany

Location

Friedrich-Schiller-University Jena

Jena, 07740, Germany

Location

Universitätsklinikum Leipzig - Klinik und Poliklinik für HNO-Heilkunde

Leipzig, 04103, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

Location

Related Publications (3)

• Inhestern J, Schmalenberg H, Dietz A, Rotter N, Maschmeyer G, Jungehulsing M, Grosse-Thie C, Kuhnt T, Gorner M, Sudhoff H, Wittekindt C, Guntinas-Lichius O. A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). Ann Oncol. 2017 Aug 1;28(8):1917-1922. doi: 10.1093/annonc/mdx202.

  PMID: 28498880 DERIVED

• Inhestern J, Oertel K, Stemmann V, Schmalenberg H, Dietz A, Rotter N, Veit J, Gorner M, Sudhoff H, Junghanss C, Wittekindt C, Pachmann K, Guntinas-Lichius O. Prognostic Role of Circulating Tumor Cells during Induction Chemotherapy Followed by Curative Surgery Combined with Postoperative Radiotherapy in Patients with Locally Advanced Oral and Oropharyngeal Squamous Cell Cancer. PLoS One. 2015 Jul 17;10(7):e0132901. doi: 10.1371/journal.pone.0132901. eCollection 2015.

  PMID: 26186556 DERIVED

• Oertel K, Spiegel K, Schmalenberg H, Dietz A, Maschmeyer G, Kuhnt T, Sudhoff H, Wendt TG, Guntinas-Lichius O. Phase I trial of split-dose induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1). BMC Cancer. 2012 Oct 20;12:483. doi: 10.1186/1471-2407-12-483.

  PMID: 23083061 DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Orlando Guntinas-Lichius, Prof. Dr.

  Friedrich-Schiller-University Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 21, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)