Trial Outcomes & Findings for Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA) (NCT NCT00304278)

Last Updated: 2017-07-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

17 weeks

Results posted on

2017-07-27

Participant Flow

Recruitment open between May 2006 and October 2009 at a small academic center outpatient otolaryngology/ oncology clinic.

Participant milestones

Participant milestones
Measure	RADPLAT and Tarceva 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 Erlotinib (Tarceva): 150 mg daily X 7 weeks Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks Radiation Therapy (RAD): 5 days per week X 7 weeks
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	RADPLAT and Tarceva 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 Erlotinib (Tarceva): 150 mg daily X 7 weeks Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks Radiation Therapy (RAD): 5 days per week X 7 weeks
Overall Study lack of insurance coverage for chemoRT	1
Overall Study PT had medical condition preventing TX	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RADPLAT and Tarceva n=21 Participants 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 Erlotinib (Tarceva): 150 mg daily X 7 weeks Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks Radiation Therapy (RAD): 5 days per week X 7 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
T stage of Tumor at diagnosis T4 stage of tumor	13 Participants n=5 Participants
T stage of Tumor at diagnosis T3 stage of tumor	8 Participants n=5 Participants
N stage of Tumor at diagnosis N0 stage of tumor	4 Participants n=5 Participants
N stage of Tumor at diagnosis N1 stage of tumor	4 Participants n=5 Participants
N stage of Tumor at diagnosis N2 Stage of tumor	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 17 weeks

Outcome measures

Outcome measures
Measure	RADPLAT and Tarceva n=19 Participants 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 Erlotinib (Tarceva): 150 mg daily X 7 weeks Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks Radiation Therapy (RAD): 5 days per week X 7 weeks
Number of Participants With Complete and Partial Response Using RECIST Criteria Complete Response	17 Participants
Number of Participants With Complete and Partial Response Using RECIST Criteria Partial Response	2 Participants

SECONDARY outcome

Timeframe: 22 months

Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates

Outcome measures

Outcome measures
Measure	RADPLAT and Tarceva n=19 Participants 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 Erlotinib (Tarceva): 150 mg daily X 7 weeks Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks Radiation Therapy (RAD): 5 days per week X 7 weeks
Survival Post Treatment	12 participants

Adverse Events

RADPLAT and Tarceva

Serious events: 11 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RADPLAT and Tarceva n=19 participants at risk 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 Erlotinib (Tarceva): 150 mg daily X 7 weeks Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks Radiation Therapy (RAD): 5 days per week X 7 weeks
Gastrointestinal disorders Nausea	26.3% 5/19
Gastrointestinal disorders Diarrhea	15.8% 3/19
Metabolism and nutrition disorders Dehydration	15.8% 3/19
Investigations Weight loss	10.5% 2/19
Gastrointestinal disorders vomiting	10.5% 2/19
General disorders Fever	10.5% 2/19
Blood and lymphatic system disorders Anemia	5.3% 1/19
Blood and lymphatic system disorders thrombocytopenia	5.3% 1/19
General disorders Hypothermia	5.3% 1/19
Vascular disorders Arterial Bleeding	5.3% 1/19
General disorders Pain	5.3% 1/19
Respiratory, thoracic and mediastinal disorders stridor	5.3% 1/19

Other adverse events

Other adverse events
Measure	RADPLAT and Tarceva n=19 participants at risk 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 Erlotinib (Tarceva): 150 mg daily X 7 weeks Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks Radiation Therapy (RAD): 5 days per week X 7 weeks
Psychiatric disorders Depression	21.1% 4/19
Respiratory, thoracic and mediastinal disorders Epistaxis	10.5% 2/19
Nervous system disorders Headache	31.6% 6/19
Respiratory, thoracic and mediastinal disorders Mucositis	68.4% 13/19
Blood and lymphatic system disorders Neutropenia	42.1% 8/19
Ear and labyrinth disorders Hearing loss	31.6% 6/19
Immune system disorders Rash	63.2% 12/19
Gastrointestinal disorders Diarrhea	52.6% 10/19
Gastrointestinal disorders Nausea	36.8% 7/19
Metabolism and nutrition disorders Dehydration	42.1% 8/19
Blood and lymphatic system disorders Anemia	47.4% 9/19
Blood and lymphatic system disorders thrombocytopenia	47.4% 9/19
Investigations weight loss	42.1% 8/19
Metabolism and nutrition disorders hypoglycemia	15.8% 3/19
General disorders pain	78.9% 15/19

Additional Information

Dr. Krishna Rao

Southern Illinois University

Phone: 217-545-7969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place