Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsor:	Swedish Orphan Biovitrum
Collaborator:	Amgen
Information provided by:	Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:	NCT00094861

Purpose

The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).

Condition	Intervention	Phase
Dysphagia Non-Small Cell Lung Cancer Lung Cancer	Drug: Palifermin Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Swallowing Disorders

Drug Information available for: Palifermin

U.S. FDA Resources

Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:

Incidence of dysphagia (CTCAE grade 2 or greater) from start of treatment through week 16. [ Time Frame: Start of treatment through week 16 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Opioid analgesic use, hospitalization, PEG/NG tube use, TPN use, IV hydration use, and infections, from start of treatment through week 16. [ Time Frame: Start of treatment through week 16 ] [ Designated as safety issue: No ]
Incidence of chronic dysphagia (CTCAE grade 2 or greater) at month 6 [ Time Frame: Six months from start of treatment ] [ Designated as safety issue: Yes ]
Incidence of pneumonitis at months 6 through 12 [ Time Frame: Six to twelve months from start of treatment ] [ Designated as safety issue: Yes ]
Disease progression, incidence of second primary tumors, other malignancies, and survival (at least once yearly for life) [ Time Frame: During a subject's lifetime from start of treatment ] [ Designated as safety issue: Yes ]
Duration of dysphagia (CTCAE grade 2 or greater) from start of treatment through week 16. [ Time Frame: Start of treatment through week 16 ] [ Designated as safety issue: No ]
Maximum severity of dysphagia from start of treatment through week 16. [ Time Frame: Start of treatment through week 16 ] [ Designated as safety issue: No ]
Incidence of severe dysphagia (CTCAE grade 3 or greater) from start of treatment through week 16. [ Time Frame: Start of treatment through week 16 ] [ Designated as safety issue: No ]
Unplanned breaks in radiotherapy (including discontinuations of radiotherapy) from start of treatment through week 7. [ Time Frame: Start of treatment through week 7 ] [ Designated as safety issue: No ]
Patient-reported outcomes- average swallowing index score from start of treatment through week 12. [ Time Frame: Start of treatment through week 12 ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	January 2005
Estimated Study Completion Date:	February 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: II	Drug: Placebo A total of approximately 50 adult subjects with unresectable stage III NSCLC will receive intravenous placebo at single weekly doses of 180 micrograms/kg to be administered on the Friday before the initiation of concurrent chemo-radiotherapy and on the last day of each chemotherapy/ radiotherapy treatment week following the last dose of radiation therapy of the week (a total of 7 doses).
Experimental: I	Drug: Palifermin A total of approximately 50 adult subjects with unresectable stage III NSCLC will receive intravenous palifermin at single weekly doses of 180 micrograms/kg to be administered on the Friday before initiation of concurrent chemo-radiotherapy and on the last day of each chemotherapy/ radiotherapy treatment week following the last dose of radiation therapy of the week (a total of 7 doses).

Arms

Assigned Interventions

Placebo Comparator: II

Drug: Placebo

A total of approximately 50 adult subjects with unresectable stage III NSCLC will receive intravenous placebo at single weekly doses of 180 micrograms/kg to be administered on the Friday before the initiation of concurrent chemo-radiotherapy and on the last day of each chemotherapy/ radiotherapy treatment week following the last dose of radiation therapy of the week (a total of 7 doses).

Experimental: I

Drug: Palifermin

A total of approximately 50 adult subjects with unresectable stage III NSCLC will receive intravenous palifermin at single weekly doses of 180 micrograms/kg to be administered on the Friday before initiation of concurrent chemo-radiotherapy and on the last day of each chemotherapy/ radiotherapy treatment week following the last dose of radiation therapy of the week (a total of 7 doses).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a histologically or cytologically proven diagnosis of NSCLC
Unresectable (locally advanced) stage IIIa or IIIb disease
Initial RT field of treatment to encompass greater than or equal to 30% of the esophagus
Life expectancy greater than or equal to 6 months
Estimated weight loss less than or equal to 10% in the 3 months before study randomization
Measurable disease
18 years of age or older
ECOG performance status of 0 - 2
Hemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L without growth factor use in the 2 weeks before study randomization
Platelet count greater than or equal to 100 x 10^9/L
Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN)
Serum creatinine less than or equal to 2.0 mg/dL (Note: Subjects with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min)
Females of childbearing potential: negative serum or urine pregnancy test
Subject must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product.
Subjects with reproductive capability must agree to practice adequate contraception methods.

Exclusion Criteria:

Metastatic disease (M1)/stage 4 NSCLC
Pleural or pericardial effusion greater than 100ml in volume as documented by appropriate imaging (PET, CT scan or ultrasound). If an effusion greater than 100ml is documented by cytology to be free from malignancy and the investigator feels the subject is capable of receiving CT/ RT for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusions should be evaluated by cytology. Sponsor approval must be obtained before subject is randomized.
Plan to remove the tumor surgically before completing the protocol CT/RT course
Shielding of any part of the esophagus during RT (including posterior spinal cord shielding)
Prior chemotherapy, radiotherapy, or surgery for NSCLC
Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Subjects with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before subject is randomized.
Presence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc)
History of pancreatitis
Four weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment
Previous treatment on this study or with a fibroblast growth factor
Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
Pregnant or breastfeeding women
Known sensitivity to E coli derived products
Compromised ability of the subject to give written informed consent and/or to comply with study procedures
Refusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable
Unwilling or unable to complete the PRO questionnaires
Psychological, social, familial, or geographical reasons that would prevent regular follow-up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094861

Sponsors and Collaborators

Swedish Orphan Biovitrum

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Development, Biovitrum AB (publ)
ClinicalTrials.gov Identifier:	NCT00094861 History of Changes
Other Study ID Numbers:	20030185
Study First Received:	October 27, 2004
Last Updated:	February 27, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Agencia Española de Medicamentos y Productos Sanitarios; United States: Food and Drug Administration

Keywords provided by Swedish Orphan Biovitrum:

dysphagia
palifermin, KGF
chemoradiotherapy
NSCLC, non-small cell lung cancer
lung cancer

supportive care
clinical trial
consolidation chemotherapy
radiotherapy

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Deglutition Disorders
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012