Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck

NCT02061631 | Completed Phase 2

• 2 other identifiers: DOCETL06445U1111-1131-0614
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer Secondary Objective: To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)

  Day 21 after cycle 3

Secondary Outcomes (3)

• Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)

  8 weeks after end of chemoradiotherapy

• Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)

  From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first

• Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)

  From Day 1 chemoradiotherapy up to or 30 days after the last day of radiotherapy

Study Arms (1)

Docetaxel, Cisplatin

EXPERIMENTAL

Induction:One-hour intravenous infusion of docetaxel at 75 mg/m2 followed by a 30 minute intravenous infusion of cisplatin at 75 mg/m2. All patients to be pre-medicated with oral dexamethasone at 8 mg twice daily for 3 days, commencing one day before docetaxel infusion. All patients will be premedicated with intravenous dexamethasone 20 mg to be administered before cisplatin infusion. Docetaxel and cisplatin treatments to be repeated every 21 days for three cycles. Chemoradiotherapy (CRT): Cisplatin to be administered by 30 minutes intravenous infusion at a dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy for a period of 6 weeks. Intravenous cisplatin to be continued for four weeks. Radiotherapy: Gross disease dose will be 60 Gy/30 fractions and sub clinical dose 45-50 Gy/30 fractions.

Drug: Cisplatin; Drug: DOCETAXEL XRP6976; Drug: Dexamethasone

Interventions

Cisplatin DRUG

Pharmaceutical form:solution Route of administration: intravenous

Docetaxel, Cisplatin

DOCETAXEL XRP6976 DRUG

Pharmaceutical form:solution Route of administration: intravenous

Docetaxel, Cisplatin

Dexamethasone DRUG

Pharmaceutical form:tablet Route of administration: oral

Docetaxel, Cisplatin

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases.
• No prior chemotherapy or radiation therapy.
• Having at least one measurable lesion in one dimension.
• Age ≥18 and \<65 years with Eastern Cooperative Oncology Group ≤ 1.
• Adequate organ function:
• Adequate hematological function
• Adequate hepatic function
• Renal function within normal limits

You may not qualify if:

• Being treated concomitantly with corticosteroids (except as pre-medication).
• Patients having another type of cancer.
• Previous chemotherapy or radiotherapy.
• Any previous definitive surgery for squamous cell carcinoma of head and neck.
• Severe weight loss (\> 20 % of body weight) in the preceding 3 months.
• Hearing loss (\> grade 2).
• Pregnancy (pregnancy test result for women of childbearing potential).
• Sexually active females with lack of adequate contraception.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Unknown Facility

Pakistan, Pakistan

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Dexamethasone

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 13, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

PA (1)