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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259675
First Posted: November 29, 2005
Last Update Posted: November 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Saskatchewan
  Purpose
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.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: carboplatin/gemcitabine, carboplatin/taxol Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Stages IIIB and IV, Non Small Cell Lung Cancer With Alternating Cycles of Carboplatin/Taxol and Carboplatin/Gemcitabine.

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • clinical response

Secondary Outcome Measures:
  • progression free survival
  • 1 year survival
  • safety and tolerability of regimen

Estimated Enrollment: 100
Study Start Date: May 2004
Study Completion Date: May 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259675


Locations
Canada, Saskatchewan
Saskatoon cancer ctr
Saskatoon, Saskatchewan, Canada, S7N4H4
Sponsors and Collaborators
University of Saskatchewan
Investigators
Study Chair: Imran Ahmad, MD Saskatchewan Cancer Agency
  More Information

ClinicalTrials.gov Identifier: NCT00259675     History of Changes
Other Study ID Numbers: BIO-REB 04-99
First Submitted: November 28, 2005
First Posted: November 29, 2005
Last Update Posted: November 15, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Carboplatin
Paclitaxel
Albumin-Bound Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators