Docetaxel And Cisplatin With or Without Erlotinib For Metastatic Or Recurrent Squamous Cell Carcinoma Of Head And Neck

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
OSI Pharmaceuticals
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01064479
First received: February 5, 2010
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research study is to learn if adding Tarcevaâ (Erlotinib, OSI-774) to the combination of docetaxel and cisplatin/carboplatin can help control SCCHN better than chemotherapy alone, in patients with SCCHN that has spread to other parts of the body or has come back after treatment. The safety of this drug combination will also be studied.


Condition Intervention Phase
Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck
Drug: Cisplatin
Drug: Docetaxel
Drug: Erlotinib
Other: Placebo
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel And Cisplatin With Or Without Erlotinib In Patients With Metastatic Or Recurrent Squamous Cell Carcinoma Of the Head And Neck

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Median Progression Free Survival of Patients from 4 Months to 6.5 Months [ Time Frame: 4 Months for Arm B to 6.5 Months in Arm A ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A = Chemo + Erlotinib
Docetaxel 75 mg/m2 IV followed by cisplatin 75 mg/m2 IV or carboplatin AUC 6 mg.min/ml on Day 1 of each 21 day cycle for a maximum of 6 cycles, plus erlotinib 150 mg PO daily continuously. A total of six cycles are planned, and a minimum of 4 cycles of chemotherapy are strongly encouraged. For patients with a complete or partial response or stable disease, erlotinib 150 mg PO daily will be continued beyond chemotherapy until disease progression.
Drug: Cisplatin
75 mg/m2 by vein (IV) once on Day 1 of every 3 week cycle 2 hours after receiving Docetaxel, up to 6 cycles.
Other Names:
  • Platinol
  • Platinol-AQ
  • CDDP
Drug: Docetaxel
75 mg/m2 IV Day 1 of each 3 week cycle, up to 6 cycles.
Other Name: Taxotere
Drug: Erlotinib
150 mg by mouth (PO) daily continuously.
Other Names:
  • Tarceva
  • OSI-774
  • Erlotinib Hydrochloride
Placebo Comparator: Arm B = Chemo + Placebo
Docetaxel 75 mg/m2 IV followed by cisplatin 75 mg/m2 IV or carboplatin AUC 6 mg.min/ml on Day 1 of each 21 day cycle for a maximum of 6 cycles, plus placebo 150 mg PO daily continuously. A total of six cycles are planned, and a minimum of 4 cycles of chemotherapy are strongly encouraged. For patients with a complete or partial response or stable disease, placebo 150 mg PO daily will be continued beyond chemotherapy until disease progression.
Drug: Cisplatin
75 mg/m2 by vein (IV) once on Day 1 of every 3 week cycle 2 hours after receiving Docetaxel, up to 6 cycles.
Other Names:
  • Platinol
  • Platinol-AQ
  • CDDP
Drug: Docetaxel
75 mg/m2 IV Day 1 of each 3 week cycle, up to 6 cycles.
Other Name: Taxotere
Other: Placebo
Tablet by mouth (PO) daily continuously.
Drug: Carboplatin
AUC 6 mg.min/ml on Day 1 of each 21 day cycle for a maximum of 6 cycles.
Other Name: Paraplatin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed metastatic or recurrent SCCHN of the oral cavity, oropharynx, hypopharynx or larynx. Metastatic or recurrent lesions of the nasopharynx and sinus are excluded.
  2. Radiologically measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan. Measurable lymph nodes are required to be >/= 15 mm in size (short axis diameter).
  3. Age >/= 18 years
  4. ECOG PS </= 2
  5. Adequate bone marrow, hepatic and renal function defined by: ANC >/= 1.5 x 109/L; Platelet count >/= 100 x 109/L; Total bilirubin </= ULN (excluding Gilbert's disease); ALT (SGPT) </= 1.5 x ULN; Alkaline phosphatase </= 2.5 x ULN; Serum creatinine </= 1.5 x ULN.
  6. Patients with reproductive potential (eg, females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) </= 14 days prior to treatment initiation.
  7. Written informed consent to participate in the study according to the investigational review board (IRB) or independent ethics committee (IEC).

Exclusion Criteria:

  1. Histology other than squamous cell carcinoma.
  2. Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx.
  3. Prior palliative chemotherapy for metastatic or recurrent disease.
  4. Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to randomization.
  5. Patients with known, untreated brain metastases. Patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed more than 28 days prior to study entry and if clinical neurologic function is stable.
  6. Pre-existing peripheral neuropathy >/= grade 2.
  7. History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (eg, Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted.
  8. Other active malignancies requiring chemotherapy treatment within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial, resected melanoma.
  9. Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
  10. History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80.
  11. Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer.
  12. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
  13. Women who are pregnant or breast-feeding and women or men not practicing effective birth control.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064479

Contacts
Contact: William N. William Jr., MD 713-792-6363

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: William N. William, Jr, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
Sanofi
Investigators
Study Chair: William N. William Jr., MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01064479     History of Changes
Other Study ID Numbers: 2009-0395, NCI-2011-03782
Study First Received: February 5, 2010
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
SCCHN
Oral cavity
Oropharynx
Hypopharynx
Larynx
Tarceva
Erlotinib
OSI-774
Docetaxel
Taxotere
Cisplatin
Platinol
CDDP
Placebo
Chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cisplatin
Carboplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014