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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Dysphagia, Non-Small Cell Lung Cancer, Lung Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Incidence of dysphagia (CTCAE grade 2 or greater) from start of treatment through week 16.

Outcome Time Frame:

Start of treatment through week 16

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

20030185

NCT ID:

NCT00094861

Start Date:

January 2005

Completion Date:

February 2015

Related Keywords:

  • Dysphagia
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • dysphagia
  • palifermin, KGF
  • chemoradiotherapy
  • NSCLC, non-small cell lung cancer
  • lung cancer
  • supportive care
  • clinical trial
  • consolidation chemotherapy
  • radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Deglutition Disorders
  • Lung Neoplasms

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