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

NCT ID: NCT01333696

Last Updated: 2013-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Squamous Cell Carcinoma of Head and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemetrexed

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

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

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

Interventions

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Pemetrexed

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

Intervention Type DRUG

Other Intervention Names

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Alimta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ye Guo

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ye Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ye Guo, MD

Role: CONTACT

86 21 64175590 ext. 8906

Facility Contacts

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Ye Guo, MD

Role: primary

86 21 64175590 ext. 8906

Other Identifiers

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HNTG 11-01

Identifier Type: -

Identifier Source: org_study_id

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