Ph II Study Examining Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation &/or Chemotherapy

• Sponsor: Barbara Ann Karmanos Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00258310
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Months): 86
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: capecitabine; Procedure: Surgery, chemotherapy and/or radiotherapy	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy.

Secondary

• Determine the time to recurrence, local-regional control, and survival rate in patients treated with this drug.

• Determine the incidence of second primary tumors in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine (Xeloda®) in Newly Diagnosed Head and Neck Squamous Cell Carcinoma (HNSCC) After Surgery, Radiation and/or Chemotherapy
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Capecitabine Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.	Drug: capecitabine; Capecitabine 1000mg/day for one year; Other Names: Xeloda ; Procedure: Surgery, chemotherapy and/or radiotherapy; Surgery, chemotherapy and/or radiotherapy

Outcome Measures

Primary Outcome Measures

1. Feasibility of Treatment as Assessed. [within 365 days]

   Compliance was taking at least 80% of the prescribed dose for one year.

Secondary Outcome Measures

1. Time to Recurrence [assessed from time of study entry until documented]

2. Local-regional Control Rate Occurrence [within 365 days]

3. Survival Rate [from time of study entry until death]

4. Incidence of Second Primary Tumor Occurrence [Every 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following primary tumor sites:

• Oral cavity

• Oropharynx

• Nasopharynx

• Hypopharynx

• Larynx

• Unknown primary

• Any disease stage allowed

• No evidence of active disease

• Must have undergone curative surgical resection, radiotherapy, and/or chemotherapy at least 1 month, but no more than 4 years ago

PATIENT CHARACTERISTICS:

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• White blood count (WBC) ≥ 3,000/mm^3

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Hepatitis B and/or C negative

Renal

• Creatinine clearance > 50 mL/min

Cardiovascular

• No myocardial infarction within the past 12 months

• No uncontrolled congestive heart failure

• No unstable or uncontrolled angina

Gastrointestinal

• No lack of physical integrity of the upper gastrointestinal tract

• Must be able to swallow tablet

• No malabsorption syndrome

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer for which the patient is currently in complete remission

• No history of uncontrolled seizures, central nervous system (CNS) disorders, or psychiatric disability that would preclude study compliance or giving informed consent

• No ongoing postoperative fistula

• No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil

• No other serious uncontrolled medical or surgical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Chemotherapy

• See Disease Characteristics

• Prior oral fluoropyrimidine therapy allowed provided it was given in the adjuvant setting and completed ≥ 12 months ago

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

• More than 4 weeks since prior major surgery and recovered

• No prior organ allografts

Other

• More than 4 weeks since prior participation in any investigational drug study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379

Sponsors and Collaborators

• Barbara Ann Karmanos Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Study Chair: George H. Yoo, MD, Barbara Ann Karmanos Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: George Yoo, Principal Investigator, Barbara Ann Karmanos Cancer Institute
• ClinicalTrials.gov Identifier: NCT00258310
• Other Study ID Numbers: CDR0000445467; P30CA022453; WSU-D-2688; WSU-HIC-120103M1F
• First Posted: Nov 24, 2005
• Last Update Posted: Jan 19, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by George Yoo, Principal Investigator, Barbara Ann Karmanos Cancer Institute: stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the nasopharynx; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Capecitabine

Study Results

Participant Flow

Arm/Group Title	Capecitabine
Arm/Group Description	Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Period Title: Overall Study
STARTED	35
COMPLETED	35
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Capecitabine
Arm/Group Description	Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Overall Participants	35
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	58
Sex: Female, Male (Count of Participants)
Female	7 20%
Male	28 80%
Region of Enrollment (participants) [Number]
United States	35 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Treatment as Assessed.
Description	Compliance was taking at least 80% of the prescribed dose for one year.
Time Frame	within 365 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Capecitabine
Arm/Group Description	Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Measure Participants	35
Number (95% Confidence Interval) [percentage of participants]	74 211.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Capecitabine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	proportion
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; .59 to .90
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Time to Recurrence
Time Frame	assessed from time of study entry until documented

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Local-regional Control Rate Occurrence
Time Frame	within 365 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Survival Rate
Time Frame	from time of study entry until death

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Incidence of Second Primary Tumor Occurrence
Time Frame	Every 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Capcitabine
Arm/Group Description	Caoecutabube 1000mg/day for one year capecitabine adjuvant therapy
All Cause Mortality
	Capcitabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Capcitabine
	Affected / at Risk (%)	# Events
Total	2/35 (5.7%)
Cardiac disorders
Respiratory Failure	1/35 (2.9%)	1
General disorders
Hand Foot Syndrome	2/35 (5.7%)	2
Other (Not Including Serious) Adverse Events
	Capcitabine
	Affected / at Risk (%)	# Events
Total	3/35 (8.6%)
Gastrointestinal disorders
Nausea/vomiting	3/35 (8.6%)	3

Limitations/Caveats

There were no significant limitations.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.