Lung Cancer Clinical Trial
Official title:
A Phase II Trial of High Dose Paclitaxel, Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer
Verified date | April 2013 |
Source | Fox Chase Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
peripheral stem cell transplantation in treating patients who have metastatic cancer.
Status | Completed |
Enrollment | 3 |
Est. completion date | February 2003 |
Est. primary completion date | November 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma Any primary site or
unknown primary site Extensive or metastatic disease Lung primaries must have at least one
of the following: Contralateral hilar adenopathy Contralateral supraclavicular adenopathy
Malignant pleural effusion Distant metastases No brain metastases or CNS involvement
Stable or responding disease to prior standard therapy allowed Measurable or evaluable
disease prior to standard therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No overt renal failure Cardiovascular: Ejection fraction at least 45% No myocardial infarction within past 6 months No congestive heart failure No significant cardiac arrhythmia No poorly controlled hypertension Pulmonary: FEV1 and DLCO at least 45% predicted No severe pulmonary disease Other: HIV negative No AIDS No other prior or concurrent malignancies within the past 5 years except basal or squamous cell skin cancer No severe medical illness (e.g., active peptic ulcer disease or brittle or uncontrolled insulin dependent diabetes) No severe or uncontrolled psychiatric illness (e.g., severe depression) No history of drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 3 months prior to, during and 3 months after study No hypersensitivity to E. coli derivatives PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: 2 prior courses of standard therapy of etoposide and a platinum analog required No other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 3 weeks since prior major surgery |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fox Chase Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the one year progression-free survival | one year | No | |
Secondary | Overall survival; safety of regimen; CR rate; lab correlates; pharmacokinetics | five years | Yes |
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