## Protocol Section
### Identification Module
**NCT ID:** NCT00293579

**Brief Title:** Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

**Official Title:** A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

#### Organization Study ID Info
**ID:** OSU-0482
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University Comprehensive Cancer Center
### Status Module
#### Completion Date
**Date:** 2008-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-02-10

**Type:** ACTUAL

**Last Update Submit Date:** 2020-01-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-03-10

**Type:** ESTIMATED

**Results First Submit Date:** 2015-10-30

**Results First Submit QC Date:** 2016-02-11

#### Start Date
**Date:** 2006-02

**Type:** ACTUAL

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2006-02-17
**Type:** ESTIMATED
**Study First Submit Date:** 2006-02-15
**Study First Submit QC Date:** 2006-02-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ohio State University Comprehensive Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

**Detailed Description:** Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12.

Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life.

Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.

### Conditions Module

**Conditions:**

- Head and Neck Cancer

**Keywords:**

- head and neck cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 5

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

**Intervention Names:**

- Drug: Pemetrexed

**Label:** Pemetrexed

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pemetrexed

**Description:** 500 mg/m2 IV every 3 weeks for 6 cycles

**Name:** Pemetrexed

**Other Names:**

- ALIMTA

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Overall Response Rate

**Time Frame:** Up to 3 years

#### Secondary Outcomes

**Description:** Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

**Measure:** Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer

**Time Frame:** Up to 3 years

**Description:** Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).

**Measure:** Impact of Pemetrexed Chemotherapy on Quality of Life

**Time Frame:** Baseline, End of Treatment [up to 3 years]

**Description:** Overall survival was measured from the time of initial study entry to death due to any cause.

**Measure:** Overall Survival

**Time Frame:** Up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Advanced, metastatic, or recurrent head and neck cancers
* Poor risk patients with ECOG performance status of 2

Exclusion Criteria:

* Prior treatment for recurrent or metastatic disease
* No clinical or radiological evidence of brain metatases
* Patients with bone only disease are not eligible
* Patients with pleural or peritoneal effusion as only manifestation of diesase

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Columbus

**Country:** United States

**Facility:** Ohio State University

**State:** Ohio

**Zip:** 43210

#### Overall Officials

**Official 1:**

**Affiliation:** Ohio State University

**Name:** Anterpreet Neki, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Urba S, van Herpen CM, Sahoo TP, Shin DM, Licitra L, Mezei K, Reuter C, Hitt R, Russo F, Chang SC, Hossain AM, Frimodt-Moller B, Koustenis A, Hong RL. Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. Cancer. 2012 Oct 1;118(19):4694-705. doi: 10.1002/cncr.27449. Epub 2012 Mar 20.

**PMID:** 22434360

#### See Also Links

**Label:** Jamesline

**URL:** http://cancer.osu.edu

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: HIGH

- As Found: Head and Neck Cancer

### Condition Browse Module - Meshes

- ID: D000006258

- Term: Head and Neck Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M264

- Name: Pemetrexed

- Relevance: HIGH

- As Found: General

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068437

- Term: Pemetrexed

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Pemetrexed

**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

**ID:** EG000

**Other Num Affected:** 5

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** Pemetrexed

**Frequency Threshold:** 5

#### Other Events

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Hypercalcemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Increased/Thicker saliva

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Body jerking

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Gum pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE version 3

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Stomach Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Loss of balance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Increased secretions

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Increased urination

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Vocal changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE version 3

**Term:** Disorientation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Rapid Heart rate

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Bleeding from Tumor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Upper Respiratory Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE version 3

**Term:** Alkaline phosphatase

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE version 3

**Term:** ALT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE version 3

**Term:** AST

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE version 3

**Term:** Gamma-Glutamyl transpeptidase

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE version 3

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 5

**Units:** Participants

### Group

**ID:** BG000

**Title:** Pemetrexed

**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 49

**Upper Limit:** 71

**Value:** 52

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** Anterpreet.Neki@osumc.edu
**Organization:** Ohio State University Comprehensive Cancer Center
**Phone:** 614-257-2900
**Title:** Anterpreet Neki
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 141.6
- **Upper Limit:** 
- **Value:** 524
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 185.9
- **Upper Limit:** 
- **Value:** 335.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.4
- **Spread:** 
- **Upper Limit:** 15.4
- **Value:** 4.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Up to 3 years
**Title:** Overall Response Rate
**Type:** PRIMARY
**Unit of Measure:** patients
##### Group
**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
**ID:** OG000
**Title:** Pemetrexed
#### Outcome Measure 2
**Description:** Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Up to 3 years
**Title:** Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer
**Type:** SECONDARY
**Unit of Measure:** percent of patients
##### Group
**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
**ID:** OG000
**Title:** Pemetrexed
#### Outcome Measure 3
**Description:** Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, End of Treatment [up to 3 years]
**Title:** Impact of Pemetrexed Chemotherapy on Quality of Life
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles
**ID:** OG000
**Title:** Pemetrexed
#### Outcome Measure 4
**Description:** Overall survival was measured from the time of initial study entry to death due to any cause.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** All patients were deceased at the time of terminating this study.
**Reporting Status:** POSTED
**Time Frame:** Up to 2 years
**Title:** Overall Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
**ID:** OG000
**Title:** Pemetrexed
### Participant Flow Module
#### Group
**Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
**ID:** FG000
**Title:** Pemetrexed
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Recruitment Details:** Patients were enrolled to the study from March 2006 to January 2008
**Has Results:** True