STA-4783 in Combination With Paclitaxel and Carboplatin for the Treatment of Chemotherapy Naive Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
A Phase I/II Trial of STA-4783 in Combination With Paclitaxel and Carboplatin for the Treatment of Chemotherapy Naive Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
86
1 country
19
Brief Summary
This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had chemotherapy before for their disease. The first phase of the study recently completed and for the second phase of the study patients are randomly assigned to receive either paclitaxel and carboplatin or paclitaxel and carboplatin and study drug (STA 4783). Treatment will be every 3 weeks for 6 cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2004
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 20, 2004
CompletedFirst Posted
Study publicly available on registry
July 21, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedDecember 4, 2008
December 1, 2008
July 20, 2004
December 3, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Histologically and/or cytologically proven NSCLC (mixed forms with small cell lung cancer are excluded) with clinically stage IIIB or stage IV disease.
- No prior systemic chemotherapy treatment.
- Prior treatments with radiotherapy or local ablative therapies are allowed if these therapies do not affect the measurable target lesions being used for the purposes of this protocol. Completion of any radiotherapy must be greater than or equal to 4 weeks prior to study entry, and/or resolution of all acute toxic effects of any prior radiotherapy or major surgical procedure to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade less than or equal to 1.
- Evidence of unidimensionally measurable disease (ie, greater than or equal to 1 malignant tumor mass that may be accurately measured in at least 1 dimension greater than or equal to 20 mm with conventional radiographic techniques or magnetic resonance imaging \[MRI\], or greater than or equal to 10 mm with spiral computerized tomography \[CT\] scan). Tumor evaluation by positron emission tomography (PET) scan or by ultrasound may not substitute for CT or MRI scans. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions, and disease documented by indirect evidence only (eg, by laboratory tests such as alkaline phosphatase) are not considered measurable.
- Female or male, 18 years of age or older.
- ECOG performance status 0 or 1.
- Neuropathy of Grade 0 or Grade 1.
- Adequate organ function as defined by the following criteria:
- Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase \[SGOT\]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase) \[SGPT\] less than or equal to 2.5 x central laboratory upper limit of normal (ULN). If liver function abnormalities are due to underlying malignancy, then AST and ALT may be less than or equal to 5 x ULN.
- Total serum bilirubin less than or equal to 1.5 x ULN
- Prothrombin time (PT) and partial thromboplastin time (PTT) less than or equal to 1.5x ULN
- Absolute neutrophil count (ANC) greater than or equal to 1500/mL
- Platelets greater than or equal to 100,000/mL
- Hemoglobin greater than or equal to 9.0 g/dL
- Serum creatinine less than or equal to 1.5 x ULN
- +3 more criteria
You may not qualify if:
- Patients with large untreated pleural effusions, or who have immediate life-threatening complications of their disease, or those who may need urgent radiotherapy (e.g., due to lobar obstruction, painful bony sites, cord compression, or superior vena cava syndrome).
- Current participation in another clinical drug trial; may not be receiving an investigational drug or any other agent that has an immunomodulatory or presumed anti-tumor effect within 4 weeks of study entry.
- Known brain metastases, or leptomeningeal disease on screening CT or MRI scan, except for treated disease that is considered clinically and radiologically stable, and does not require treatment with anti-convulsants and/or steroids.
- Prior malignancy other than NSCLC within the last 5 years with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri;
- Basal or squamous cell carcinoma of the skin;
- Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.
- Has a known allergy to Cremophor® or Cremophor®-based drug products.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Pregnancy or breast feeding.
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Wilshire Oncology Medical Group
Pomona, California, 91767, United States
St. Francis Memorial Hospital
San Francisco, California, United States
Cancer Institute Medical Group
Santa Monica, California, 90404, United States
Kaiser Permanete
Vallejo, California, United States
Oncology Associates of Bridgeport
Trumball, Connecticut, 06611, United States
ACORN
Miami, Florida, United States
Oncology Hematology Consultants
Sarasota, Florida, 34236, United States
University of Chicago
Chicago, Illinois, 60637, United States
The Cancer Institute at Alexian Brothers
Elk Grove Village, Illinois, 60007, United States
Ingalls Hospital
Harvey, Illinois, 60426, United States
Overton Brooks, VAMC
Shreveport, Louisiana, 71101, United States
LSUHSC - Shreveport Feist Weiller Cancer Center
Shreveport, Louisiana, 71130, United States
Maryland Hematology and Oncology Associates
Baltimore, Maryland, 21236, United States
The Duluth Clinic
Duluth, Minnesota, 55805, United States
The West Clinic
Memphis, Tennessee, 38120, United States
The Sarah Cannon Research Center
Nashville, Tennessee, 37203, United States
Presbyterian Hospital
Dallas, Texas, 75231, United States
Multicare Health System
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 20, 2004
First Posted
July 21, 2004
Study Start
March 1, 2004
Study Completion
March 1, 2005
Last Updated
December 4, 2008
Record last verified: 2008-12