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

NCT00259675 | Completed Phase 2

• 1 other identifier: BIO-REB 04-99
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• clinical response

Secondary Outcomes (3)

• progression free survival

• 1 year survival

• safety and tolerability of regimen

Interventions

carboplatin/gemcitabine, carboplatin/taxol DRUG

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ) Previous chemotherapy for NSCLC.
• \) Known CNS metastases at time of registration.
• \) 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.
• \) 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.
• \) Known HIV positive.
• \) Palliative radiotherapy to only area of measurable disease.
• \) 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.
• \) 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).

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Saskatoon cancer ctr

Saskatoon, Saskatchewan, S7N4H4, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Gemcitabine; CP protocol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Imran Ahmad, MD

  Saskatchewan Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: May 1, 2004
• Study Completion: May 1, 2007
• Last Updated: November 15, 2007

Record last verified: 2007-05

Locations

CA (1)