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Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer (SPECTRUM)

Primary Purpose

Recurrent and/or Metastatic Head and Neck Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ARM 2

ARM 1

About this trial

This is an interventional treatment trial for Recurrent and/or Metastatic Head and Neck Cancer focused on measuring Squamous Cell Carcinoma, Epidermal Growth Factor, Epidermal Growth Factor Receptor, SCCHN, Metastatic Head and Neck Cancer, EGFr, Head and Neck Cancer, Recurrent Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Man or woman at least 18 years old.
Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
Measurable and non-measurable disease.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

History or known presence of Central Nervous System (CNS) metastases.
History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
Nasopharyngeal carcinoma.
Prior systemic treatment for metastatic and/or recurrent SCCHN
Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ARM 2

ARM 1

Arm Description

Arm 2 consists of Cisplatin and 5-FU

ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU

Outcomes

Primary Outcome Measures

Overall Survival

Time from randomization to death

Secondary Outcome Measures

Overall Response Rate

An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.

Duration of Response

Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).

Time to Progression

Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)

Time to Response

Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.

Progression Free Survival

Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.

Full Information

NCT ID

NCT00460265

First Posted

April 12, 2007

Last Updated

February 3, 2014

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00460265

Brief Title

Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Acronym

SPECTRUM

Official Title

A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent and/or Metastatic Head and Neck Cancer

Keywords

Squamous Cell Carcinoma, Epidermal Growth Factor, Epidermal Growth Factor Receptor, SCCHN, Metastatic Head and Neck Cancer, EGFr, Head and Neck Cancer, Recurrent Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

658 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM 2

Arm Type

Active Comparator

Arm Description

Arm 2 consists of Cisplatin and 5-FU

Arm Title

ARM 1

Arm Type

Experimental

Arm Description

ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU

Intervention Type

Drug

Intervention Name(s)

ARM 2

Intervention Description

Subjects will receive Cisplatin plus 5FU

Intervention Type

Drug

Intervention Name(s)

ARM 1

Intervention Description

Subjects will receive Panitumumab plus cisplatin and 5FU

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time from randomization to death

Time Frame

Upto 56 months

Secondary Outcome Measure Information:

Title

Overall Response Rate

Description

Time Frame

Every 6 weeks until disease progression, up to 56 months

Title

Duration of Response

Description

Time Frame

Every 6 weeks until disease progression, up to 56 months

Title

Time to Progression

Description

Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)

Time Frame

Every 6 weeks until disease progression, up to 56 months

Title

Time to Response

Description

Time Frame

Every 6 weeks until disease progression, upto 56 months

Title

Progression Free Survival

Description

Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.

Time Frame

Every 6 weeks until disease progression or deaths, upto 56 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Man or woman at least 18 years old. Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck. Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy. Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy. Measurable and non-measurable disease. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: History or known presence of Central Nervous System (CNS) metastases. History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization. Nasopharyngeal carcinoma. Prior systemic treatment for metastatic and/or recurrent SCCHN Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan. Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0 Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

Citation

Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521;

Results Reference

background

PubMed Identifier

23746666

Citation

Vermorken JB, Stohlmacher-Williams J, Davidenko I, Licitra L, Winquist E, Villanueva C, Foa P, Rottey S, Skladowski K, Tahara M, Pai VR, Faivre S, Blajman CR, Forastiere AA, Stein BN, Oliner KS, Pan Z, Bach BA; SPECTRUM investigators. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697-710. doi: 10.1016/S1470-2045(13)70181-5. Epub 2013 Jun 6.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

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Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer

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