Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)

NCT00304278 | Completed Phase 2 Results DMC

• 2 other identifiers: RAO-OSI-3601SGenentech, Inc.
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Erlotinib; RADPLAT

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete and Partial Response Using RECIST Criteria

  Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD

  17 weeks

Secondary Outcomes (1)

• Survival Post Treatment

  22 months

Study Arms (1)

RADPLAT and Tarceva

EXPERIMENTAL

All patients will receive RADPLAT and Tarceva: Drug: Erlotinib (Tarceva) 150 mg daily X 7 weeks Other Names: Tarceva Drug: Intra-arterial Cisplatin (PLAT) 1 dose (150 mg/sq) per week X 4 weeks Other Names: Cisplatin Radiation: Radiation Therapy (RAD) 5 days per week X 7 weeks

Drug: Erlotinib (Tarceva); Drug: Intra-arterial Cisplatin (PLAT); Radiation: Radiation Therapy (RAD)

Interventions

Erlotinib (Tarceva) DRUG

150 mg daily X 7 weeks

Also known as: Tarceva

RADPLAT and Tarceva

Intra-arterial Cisplatin (PLAT) DRUG

1 dose (150 mg/sq) per week X 4 weeks

Also known as: Cisplatin

RADPLAT and Tarceva

Radiation Therapy (RAD) RADIATION

5 days per week X 7 weeks

RADPLAT and Tarceva

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx.
• No previous radiation therapy or chemotherapy.
• No evidence of distant metastatic disease.
• Age \> 18.
• Karnofsky performance status of \> 60 (ECOG 2).
• ANC \> 1000, platelets \> 100,000, calculated or 24-hour creatinine clearance \> 60.
• Study-specific informed consent form.
• Protocol treatment must begin \< 8 weeks of diagnostic biopsy.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients with surgically cured secondary malignancy who have been disease free \> 5 years are eligible.

You may not qualify if:

• Radiologic evidence of bone destruction.
• Previous or concurrent head and neck primaries.
• Prior surgery to study site other than biopsy.
• Patients receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because treatments and agents have the potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• History of a prior or concomitant malignancy (other than carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin).

Sponsors & Collaborators

• Southern Illinois University: lead
• Genentech, Inc.: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (1)

Simmons Cooper Cancer Institute/SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Links

• official website of the SimmonsCooper Cancer Institute at SIU

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Erlotinib Hydrochloride; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Results Point of Contact

• Title: Dr. Krishna Rao
• Organization: Southern Illinois University

krao@siumed.edu

217-545-7969

Study Officials

• Krishna Rao, MD, PhD

  SIU School of Medicine

  PRINCIPAL INVESTIGATOR

• Thomas Robbins, MD

  Simmons Cancer Institute at SIU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 17, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-06

Locations

US (1)