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Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pemetrexed

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Squamous cell carcinoma of head and neck, Pemetrexed

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age range: 18-65 years old
Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
Prior exposure of at least one line of platinum-containing regimen
At least one site of measurable disease according to RECIST criteria
ECOG performance status 0-1
Life expectancy of more than 3 months
Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
Liver function: total bilirubin, ALT and AST <1.5×UNL
Renal function: Cr<1.5×UNL, CCR≧45ml/min

Exclusion Criteria:

With curable treatment option
Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Significant active infection
Pregnant or lactating women

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed

Arm Description

500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Median progression-free survival

Median overall survival

Full Information

NCT ID

NCT01333696

First Posted

April 11, 2011

Last Updated

March 2, 2013

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01333696

Brief Title

Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

Official Title

Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

Detailed Description

The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.

6. Conditions and Keywords

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

Squamous Cell Carcinoma of Head and Neck

Keywords

Squamous cell carcinoma of head and neck, Pemetrexed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed

Arm Type

Experimental

Arm Description

500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks

Primary Outcome Measure Information:

Title

Overall response rate

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Median progression-free survival

Time Frame

1 year

Title

Median overall survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age range: 18-65 years old Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck Prior exposure of at least one line of platinum-containing regimen At least one site of measurable disease according to RECIST criteria ECOG performance status 0-1 Life expectancy of more than 3 months Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L Liver function: total bilirubin, ALT and AST <1.5×UNL Renal function: Cr<1.5×UNL, CCR≧45ml/min Exclusion Criteria: With curable treatment option Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Significant active infection Pregnant or lactating women

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ye Guo, MD

Phone

86 21 64175590

Ext

8906

pattrick_guo@msn.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

Phone

86 21 64175590

Ext

8906

pattrick_guo@msn.com

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

12. IPD Sharing Statement

Learn more about this trial

Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

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