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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)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer

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Trial Information

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)


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

- 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

- The effects of STA-4783 on the developing human fetus are unknown, however, taxanes
and platinum analogues are known to be teratogenic. Therefore, women of childbearing
potential (defined as, unless surgically sterile, women <=50 years of age or history
of amenorrhea for < 12 months prior to study entry) must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation. Should a female patient
become pregnant or suspect she is pregnant while participating in this study, she
must agree to inform the treating physician immediately, and be followed until
delivery.

- Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment.

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.

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.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

4783-02

NCT ID:

NCT00088088

Start Date:

March 2004

Completion Date:

March 2005

Related Keywords:

  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Oncology Hematology ConsultantsSarasota, Florida  34239
University of ChicagoChicago, Illinois  60637
Wilshire Oncology Medical GroupGlendora, California  91741
Cancer Institute Medical GroupLos Angeles, California  90025
The West ClinicMemphis, Tennessee  38120
St. Francis Memorial HospitalSan Francisco, California  94109
Ingalls HospitalHarvey, Illinois  60426
Multicare Health SystemTacoma, Washington  98415
NEA ClinicJonesboro, Arkansas  72401
Kaiser PermaneteVallejo, California  
Oncology Associates of BridgeportTrumball, Connecticut  06611
ACORNMiami, Florida  
The Cancer Institute at Alexian BrothersElk Grove Village, Illinois  60007
LSUHSC - Shreveport Feist Weiller Cancer CenterShreveport, Louisiana  71130
Overton Brooks, VAMCShreveport, Louisiana  71101
Maryland Hematology and Oncology AssociatesBaltimore, Maryland  21236
The Duluth ClinicDuluth, Minnesota  55805
The Sarah Cannon Research CenterNashville, Tennessee  37203
Presbyterian HospitalDallas, Texas  75231