Alternating Cycles of Carboplatin/Gemcitabine and Carboplatin/Taxol for Advanced Stage NSCLC

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Histologically/cytologically documented Non Small Cell Lung Carcinoma.

2. Stages IIIB and IV disease, not a candidate for definitive treatment with surgery, radiation or radiation plus chemotherapy. (Palliative radiotherapy will be allowed).

3. Age ≥ 18, < 75 years.

4. ECOG performance status 2

5. No serious concomitant psychiatric illness.

6. Informed consent.

7. Presence of measurable or evaluable disease on physical examination, CT scan, chest x-ray, ultrasound or MRI scan.

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Exclusion Criteria:

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).