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Non-small cell lung cancer refractory to platinum-based therapy



Non-small cell lung cancer refractory to platinum-based therapy

For Condition: Carcinoma, Non-Small-Cell Lung
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen. A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: A physician participating in the study will determine eligibility, but if you meet the following criteria, you may qualify for this study: - Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent. - Recovery from all acute side effects of prior therapies (with the exception of hair loss). - Adequate bone marrow, liver, and kidney function Exclusion Criteria: - More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens). - Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study. - Symptomatic brain metastases. - HIV, hepatitis B and/or hepatitis C infection. - Serious health problems such as uncontrolled serious infections, disabling heart disease, or uncontrolled major seizure disorder. - History of allergic reactions to docetaxel or paclitaxel. - Prior exposure to MAC-321.
Total Enrollment: 

Location and Contact Information:

University of Sourthern California, Norris Comprehensive Cancer Center *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Derek  Raghavan 323-865-3962

University of Minnesota, Department of Medicine/HOT *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Arkadiusz  Dudek 612-624-6490

Markey Cancer Center *Recruiting*
Lexington,  Kentucky,  40536-0098
United States
Recruiting Susanne  Arnold 859-257-3379

Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Carol  Sherman 843-792-0670

Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Harry  Raftopoulos 212-305-0787

John Hopkins Hospital Oncology Center *Recruiting*
Baltimore,  Maryland,  21231-1000
United States
Recruiting Julie  Brahmer 410-614-6139

Vanderbilt University *Recruiting*
Nashville,  Tennessee,  37232
United States
Recruiting Alan  Sandler 800-811-8480

University of Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15213
United States
Recruiting Chandra  Belani 412-647-8569

Fox Chase/Temple Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19140
United States
Recruiting Joseph  Treat 215-707-7410

Siteman Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Ramaswamy  Govindan 314-747-4235

University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Kishan  Pandya 585-275-8213

H. Lee Moffitt Cancer Center *Recruiting*
Tampa,  Florida,  33612
United States
Recruiting Alberto  Chiappori 813-972-8393

UMass Memorial Medical Center *Recruiting*
Worcester,  Massachusetts,  01655
United States
Recruiting Jeff  Gordon 508-334-6077

Carolinas Hematology-Oncology Associates *Recruiting*
Charlotte,  North Carolina,  28203
United States
Recruiting Steven  Limentani 704-355-8289

Cleveland Clinic *Recruiting*
Cleveland,  Ohio,  44195
United States
Recruiting Tarek  Mekhail 216-444-9451

Lombardi Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20057
United States
Recruiting Jimmy  Hwang 202-687-2561


Additional Information:
Study ID Numbers:
  3128K1-201-WW; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063219

Other Carcinoma, Non-Small-Cell Lung Studies:
1. Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC

2. A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin versus Gemcitabine and Cisplatin in Patients with Advanced, Previously Untreated Non-Small Cell Lung Cancer

3. Erlotinib in Treating Patients with Advanced Non-Small Cell Lung Cancer

4. Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer

5. ALIMTA (pemetrexed) Plus Gemcitabine (Gemzar) for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer who have not had Previous Chemotherapy.

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Non-small cell lung cancer refractory to platinum-based therapy

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