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PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

Primary Purpose

Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Cisplatin

Panitumumab

Docetaxel

Cisplatin

Docetaxel

About this trial

This is an interventional treatment trial for Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck focused on measuring SCCHNC, Metastatic, Recurrent

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
Measurable disease by CT scan
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Age: 18 years or older
Adequate hematologic, renal, metabolic, hepatic & thyroid function

Exclusion Criteria:

Prior systemic treatment for metastatic and/or recurrent SCCHN
CNS metastases, or nasopharyngeal carcinoma
History of interstitial lung disease
History of another primary cancer
Any co-morbid disease that would increase risk of toxicity
- Active infection requiring systemic treatment
- Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm 1

Arm 2

Arm Description

Panitumumab + Docetaxel + Cisplatin

control

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) During the First-line Treatment Phase

The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.

Secondary Outcome Measures

Overall Response Rate (ORR) During the First-line Treatment Phase

Rate of Disease Control (RDC) During the First-line Treatment Phase

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 (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.

Duration of Response (DOR) During the First-line Treatment Phase

Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

Time to Response (TTR) During the First-line Treatment Phase

Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)

Overall Survival (OS) for the First-line Treatment

Time from the date of randomization to the date of death during the entire study

Progression Free Survival (PFS) During the Second-line Treatment Phase

The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.

Overall Response Rate (ORR) During the Second-line Treatment Phase

Rate of Disease Control (RDC) During the Second-line Treatment Phase

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 (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.

Duration of Response (DOR) During the Second-line Treatment Phase

Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

Time to Response (TTR) During the Second-line Treatment Phase

Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)

Overall Survival (OS) for the Second-line Treatment

Time from the first dose of panitumumab monotherapy to the date of death during the entire study

Full Information

NCT ID

NCT00454779

First Posted

March 29, 2007

Last Updated

September 20, 2018

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00454779

Brief Title

PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

Official Title

A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2007 (Actual)

Primary Completion Date

June 11, 2012 (Actual)

Study Completion Date

January 1, 2014 (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

This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.

6. Conditions and Keywords

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

Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Keywords

SCCHNC, Metastatic, Recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Panitumumab + Docetaxel + Cisplatin

Arm Title

Arm 2

Arm Type

Other

Arm Description

control

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

chemotherapy arm

Intervention Type

Drug

Intervention Name(s)

Panitumumab

Intervention Description

experimental arm

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

chemotherapy arm

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

experimental arm

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

experimental arm

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) During the First-line Treatment Phase

Description

Time Frame

Every 6 weeks until disease progression or death, up to 67 months

Secondary Outcome Measure Information:

Title

Overall Response Rate (ORR) During the First-line Treatment Phase

Description

Time Frame

Every 6 weeks until disease progression or death, up to 67 months

Title

Rate of Disease Control (RDC) During the First-line Treatment Phase

Description

Time Frame

Every 6 weeks until disease progression or death, up to 67 months

Title

Duration of Response (DOR) During the First-line Treatment Phase

Description

Time Frame

Every 6 weeks until disease progression or death, up to 67 months

Title

Time to Response (TTR) During the First-line Treatment Phase

Description

Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)

Time Frame

Every 6 weeks until disease progression or death, up to 67 months

Title

Overall Survival (OS) for the First-line Treatment

Description

Time from the date of randomization to the date of death during the entire study

Time Frame

Until death, up to 67 months

Title

Progression Free Survival (PFS) During the Second-line Treatment Phase

Description

Time Frame