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COMPLETEDPHASE1/PHASE2

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)

NCT00088088•Synta Pharmaceuticals Corp.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+8 more criteria

Exclusion Criteria

•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.
+1 more criteria

Locations (19)

NEA Clinic

Jonesboro, Arkansas, United States

Wilshire Oncology Medical Group

Pomona, California, United States

St. Francis Memorial Hospital

San Francisco, California, United States

Cancer Institute Medical Group

Santa Monica, California, United States

Kaiser Permanete

Vallejo, California, United States

Oncology Associates of Bridgeport

Trumball, Connecticut, United States

ACORN

Miami, Florida, United States

Oncology Hematology Consultants

Sarasota, Florida, United States

University of Chicago

Chicago, Illinois, United States

The Cancer Institute at Alexian Brothers

Elk Grove Village, Illinois, United States

Key Dates

Start Date

March 1, 2004

Completion Date

March 1, 2005

Last Updated

December 4, 2008

Enrollment

Estimated participants

Conditions

Stage IIIB Non-Small Cell Lung CancerStage IV Non-Small Cell Lung Cancer

Interventions

Paclitaxel

DRUG

Carboplatin

DRUG

STA 4783

DRUG

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Head and Neck Squamous Cell CarcinomaMetastatic Pancreatic Adenocarcinoma+14 more

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ACTIVE_NOT_RECRUITING

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

NCT04056247

Stage IV Non-small Cell Lung CancerStage IV Malignant Melanoma+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer

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