Trial Outcomes & Findings for EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202) (NCT NCT00270790)

Last Updated: 2017-02-01

Results Overview

Blood work (CMP was collected and evaluated for neutropenia, leukopenia and anemia) is taken prior to chemotherapy administration. The toxicity levels were measured using Common Terminology Criteria for Adverse Events (CTCAE 3.0) and monitored based on the dose of Amifostine given.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

3 years

Results posted on

2017-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	AMIFOSTINE +2 Chemo Lines +RT EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER. Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation Carboplatin: Carboplatin for 100 mg/m2 Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
Overall Study STARTED	21
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMIFOSTINE +CARBOPLATIN, TAXOL +RT n=21 Participants EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER. Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation Carboplatin: Carboplatin for 100 mg/m2 Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	58.2 years n=99 Participants
Gender Female	3 Participants n=99 Participants
Gender Male	18 Participants n=99 Participants
Region of Enrollment United States	21 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 years

Population: 21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.

Outcome measures

Outcome measures
Measure	AMIFOSTINE +CARBOPLATIN, TAXOL +RT n=16 Participants EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER. Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation Carboplatin: Carboplatin for 100 mg/m2 Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine	16 participants

SECONDARY outcome

Timeframe: 3 years

Population: 21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	AMIFOSTINE +CARBOPLATIN, TAXOL +RT n=16 Participants EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER. Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation Carboplatin: Carboplatin for 100 mg/m2 Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
Response Rates Based on the Study Regimen	16 participants

Adverse Events

AMIFOSTINE +CARBOPLATIN, TAXOL +RT

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AMIFOSTINE +CARBOPLATIN, TAXOL +RT n=21 participants at risk EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER. Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation Carboplatin: Carboplatin for 100 mg/m2 Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
Investigations Fatigue	100.0% 21/21 • 3 years
Blood and lymphatic system disorders Neutropenia	9.5% 2/21 • 3 years
Gastrointestinal disorders Mucositis	28.6% 6/21 • 3 years
Gastrointestinal disorders Dysphagia	28.6% 6/21 • 3 years
Gastrointestinal disorders Xerostomia	19.0% 4/21 • 3 years
Blood and lymphatic system disorders Leukopenia	38.1% 8/21 • 3 years
Blood and lymphatic system disorders Thrombocytopenia	4.8% 1/21 • 3 years
Skin and subcutaneous tissue disorders Dermatitis	19.0% 4/21 • 3 years
Gastrointestinal disorders Nausea	9.5% 2/21 • 3 years
Gastrointestinal disorders Vomiting	9.5% 2/21 • 3 years
Gastrointestinal disorders Weight Loss	4.8% 1/21 • 3 years
Gastrointestinal disorders Dehydration	19.0% 4/21 • 3 years

Additional Information

Mohan Suntharalingam

University of Maryland School of Medicine

Phone: 410-328-2328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place