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

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:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Carboplatin Docetaxel Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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 2014 (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

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:

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.
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).
Age >/= 18 years
ECOG PS </= 2
Adequate bone marrow, hepatic and renal function defined by: ANC >/= 1.5 x 109/L; Platelet count >/= 100 x 109/L; Total bilirubin </= ULN; ALT (SGPT) </= 1.5 x ULN; Alkaline phosphatase </= 2.5 x ULN; Serum creatinine </= 1.5 x ULN.
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.
Written informed consent to participate in the study according to the investigational review board (IRB) or independent ethics committee (IEC).

Exclusion Criteria:

Histology other than squamous cell carcinoma.
Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx.
Prior chemotherapy for metastatic or recurrent disease.
Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to randomization.
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.
Pre-existing peripheral neuropathy >/= grade 2.
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.
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.
Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
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.
Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer.
Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Women who are pregnant or breast-feeding and women or men not practicing effective birth control.

Contacts and Locations

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

Investigators

Study Chair:

William N. William Jr., MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01064479 History of Changes
Other Study ID Numbers:	2009-0395
Study First Received:	February 5, 2010
Last Updated:	December 5, 2012
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
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013