Status:
COMPLETED
Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
AstraZeneca
Amgen
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemothera...
Detailed Description
Lung cancer remains the leading cause of cancer-related mortality in the United States. In 2002, approximately 170,000 new cases of lung cancer will be diagnosed, and approximately 160,000 deaths will...
Eligibility Criteria
Inclusion
- Subjects 18 years of age or older.
- Subjects with histologically or cytologically confirmed NSCLC that is considered generally unresectable or inoperable. No prior chemotherapy for NSCLC or thoracic radiotherapy is allowed.
- Subjects with Stage IIIA or IIIB disease (clinically or surgically staged).
- Subject with disease designated T3, N0-N1 based on mediastinal invasion or proximity to the carina.
- Subjects with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed within the radiation port.
- Subjects with pleural fluid that is a transudate and is cytologically negative.
- Subjects with pleural effusions that are seen only on CT scan and are too small to tap.
- Subjects with measurable or evaluable disease.
- Subjects with PS of 0 or 1 by the ECOG scale (see Appendix 2).
- Subjects with laboratory values as follows:
- Absolute granulocyte count: ≥1,500/µL Platelets: ≥100,000/µL Total bilirubin: ≤1.5 x institutional upper normal limit Serum creatinine: \<1.6 mg/dL or Creatinine clearance:\>40 mL/min
- AST and ALT: ≤2.5 x institutional upper normal limit FEV 1 \>800 cc
- Subjects must be nonpregnant and non-lactating. Subjects of childbearing potential must implement an effective method of contraception during the study. All female subjects, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
- Subjects must have a life expectancy \> 2 months.
- Subjects must be seen by both a medical oncologist and a radiation oncologist before registration.
- Subjects must be informed of the investigational nature of the study and must sign an informed consent form.
Exclusion
- Subjects with disease designated T3, N0-N1 based on chest wall invasion, subjects with N3 supraclavicular disease, or subjects with superior sulcus tumors.
- Subjects with cytologically positive pleural effusions.
- Subjects who have received prior chemotherapy or radiochemotherapy for lung cancer or prior chest radiotherapy.
- Subjects who are \< 3 weeks since formal exploratory thoracotomy.
- Subjects with a history of other cancers except in situ carcinoma of the cervix or breast, inactive nonmelanomatous skin cancer, or other cancer, unless the subject has been free of disease for \> 5 years.
- Also, exceptions can be made by the PI for a subject with a malignancy for which the prognosis is substantially better than the subject's prognosis for NSCLC.
- Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. Subjects with post-obstructive pneumonia remain eligible.
- Subjects with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- Pregnant or breast-feeding females or subjects not using adequate methods of birth control.
- Subjects receiving other investigational therapy or non-approved therapy within 30 days before Day 1 of protocol treatment.
- Subjects with known hypersensitivity to E coli-derived proteins, pegfilgrastim, or any component of the product will be excluded.
- Subjects with metastatic disease are excluded.
- Subjects taking phenytoin, rifampicin, barbiturates, carbamazepine, or St. John's Wort.
- Any evidence of clinically active ILD (subjects with chronic stable radiographic changes who are asymptomatic need not be excluded).
- Subjects with evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
- As judged by the investigator, subjects with any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Subjects with known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00280787
Start Date
November 1 2003
End Date
October 1 2010
Last Update
February 5 2013
Active Locations (1)
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1
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599