A study to evaluate the effects of palifermin in reducing the difficulty of swallowing in patients receiving chemoradiotehrapy and chemotherapy in lung cancer patients

• Conditions: Dysphasia; MedDRA version: 14.1Level: PTClassification code 10013950Term: DysphagiaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2004-003116-33-DE
• Lead Sponsor: Swedish Orphan Biovitrum (Sobi) AB (publ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-26
• Last Update Posted: 9 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Disease Related:
- 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 = 30% of the esophagus
- Life expectancy = 6 months
- Estimated weight loss = 10% in the 3 months before study randomization
- Measurable disease
Demographic:
- 18 years of age or older
- ECOG performance status of 0-2 (see Appendix F) Screening Laboratory:
- Hemoglobin (hgb) = 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
- Absolute neutrophil count (ANC) = 1.5 x 10e9/L without growth factor use in the 2 weeks before study randomization
- Platelet count = 100 x 10e9/L
- Serum bilirubin = 1.5 x institutional upper limit of normal (ULN)
- Serum creatinine = 2.0 mg/dL (Note: Subjects with a serum creatinine = 1.4 and = 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance = 50 mL/min.)
- Females of childbearing potential: negative serum or urine pregnancy test
Ethical:
- Subject must give written informed consent before participating in any study-specific procedure, randomization,
or receiving investigational product.
General:
- Subjects with reproductive capability must agree to practice adequate contraception methods.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

Disease Related:
- Metastatic disease (M1)/stage 4 NSCLC
- Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging ( PET, CT scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the subject is capable of receiving RT/ CT for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusion 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
Medication/Prior Treatment:
- 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
Laboratory:
- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
General:
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified