Status:
COMPLETED
Alternating Cycles of Carboplatin/Gemcitabine and Carboplatin/Taxol for Advanced Stage NSCLC
Lead Sponsor:
University of Saskatchewan
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief Summary
To see the efficacy of using chemotherapies alternatively (carboplatin and gemcitabine alternating with carboplatin and taxol) for pts with stage IIIB (nonresectable and stage IV NSCLC.
Detailed Description
Lung cancer is the leading cause of cancer death in men and women in the USA, and account for 28% of all cancer deaths in 2002 (1). In stage IV and some patients with stage III disease chemotherapy is...
Eligibility Criteria
Inclusion
- Histologically/cytologically documented Non Small Cell Lung Carcinoma.
- Stages IIIB and IV disease, not a candidate for definitive treatment with surgery, radiation or radiation plus chemotherapy. (Palliative radiotherapy will be allowed).
- Age ≥ 18, \< 75 years.
- ECOG performance status 2
- No serious concomitant psychiatric illness.
- Informed consent.
- Presence of measurable or evaluable disease on physical examination, CT scan, chest x-ray, ultrasound or MRI scan.
- \-
Exclusion
- 1 ) Previous chemotherapy for NSCLC.
- 2\) Known CNS metastases at time of registration.
- 3\) Laboratory values obtained \<28 days prior to entry
- ANC \<1.5 x 109 /L PLT \<100 x 109 /L HgB\<100 g/L Total bili \>1.5 x UNL (upper normal limit) Alk PO4 \>3 x UNL AST \>3x UNL Cr \>1.5 x UNL.
- 4\) Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other disease which in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient.
- 5\) Known HIV positive.
- 6\) Palliative radiotherapy to only area of measurable disease.
- 7\) Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated non invasive carcinomas, or other cancer from which the patient has been disease free for at least five years.
- 8\) Pregnant or nursing women. Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, IUD, abstinence, surgical sterilization etc).
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00259675
Start Date
May 1 2004
End Date
May 1 2007
Last Update
November 15 2007
Active Locations (1)
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1
Saskatoon cancer ctr
Saskatoon, Saskatchewan, Canada, S7N4H4