GW786034 in Patients With Non Small Cell Lung Cancer 3rd Line

Stopped early · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

Lung Cancer is the most common cause of cancer death in the United States with an estimated mortality in excess of 160,000, more than the combined mortality seen with prostate, breast, colorectal cancers(1). Most patients with Lung Cancer have Non-Small Cell Lung Cancers( NSCLC) and only 25-30% of patients with NSCLC (Non Small Cell Lung Cancer) have resectable disease( Stage I or II) at the time of diagnosis. The vast majority of patients with advanced NSCLC (Non Small Cell Lung Cancer) are not curable and overall five year survival is 11%-14%1. Chemotherapy is beneficial for patients with locally advanced and metastatic disease. Numerous phase III studies have determined the superiority of systemic chemotherapy over best supportive care. Platinum based chemotherapy has been widely accepted as the standard of care for the initial treatment of advanced NSCLC. However first line chemotherapy is modest at best. A randomized trial comparing four of the most commonly used chemotherapy regimens in the United States not only failed to show a clearly superior arm but also confirmed the dismal prognosis of these patients. The response rate for all 1207 patients was 18.6% with a median survival of eight months and one year survival of 33.5 % and a two year survival of 12%5. Clearly a different paradigm is needed for the treatment of this disease.

Key facts

Study ID

NCT01049776

Run by

Illinois CancerCare, P.C.

People needed

32

Starts

2010-01-01

Last updated by the study team

2014-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Required Characteristics 3.1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
• Note: It is not necessary that informed consent be obtained within the protocol-specified screening window.
• 11 ≥18 years of age.
• 12 ≥2 prior systemic therapies for Non Small Cell Lung Cancer.
• 13 Histologic or cytologic diagnosis of stage IV Non Small Cell Lung cancer
• . 3.14 Measurable disease. For patients having only lesions measuring ≥1 cm to ≤2 cm per RECIST criteria must use spiral CT imaging for both pre- and post-treatment tumor assessments.
• 15 Laboratory values obtained ≤14 days prior to registration: Hematologic Absolute neutrophil count (ANC) 1.5 X 109/L Hemoglobin1 9 g/dL (5.6 mmol/L) Platelets 100 X 109/L Prothrombin time (PT) or international normalized ratio (INR) 1.2 X upper limit of normal (ULN) Partial thromboplastin time (PTT) 1.2 X ULN Hepatic2 Total bilirubin 1.5 X ULN AST and ALT 2.5 X ULN Renal Serum creatinine 1.5 mg/dL (133 µmol/L)
• Or, if greater than 1.5 mg/dL:
• Calculated creatinine clearance 50 mL/min
• Urine Protein to Creatinine Ratio (UPC)3 < 1
• Subjects may not have had a transfusion within 7 days of screening assessment.
• Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permitted
• If UPC >/= 1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value <1g to be eligible.
• 16 ECOG Performance Score 0, or 1.
• 17 Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
• A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
• A hysterectomy
• A bilateral oophorectomy (ovariectomy)
• A bilateral tubal ligation
• Is post-menopausal
• Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
• Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
• Childbearing potential, including any female who has had a negative serum pregnancy test within 1 week prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
• An intrauterine device with a documented failure rate of less than 1% per year.
• Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.

You may not qualify if…

• 21 Any of the following as this regimen may be harmful to a developing fetus or nursing child.
• Pregnant women
• Nursing women
• Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.
• 22 Any abnormal serum calcium, magnesium, and potassium levels
• 23 Clinically significant hemoptysis, cerebral hemorrhage, or gastrointestinal hemorrhage in the past 6 months
• 24 Any patient currently on an antiarrhythmics or other medications that are know to prolong the QT interval.
• 25 Uncontrolled infection.
• 26 Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
• Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study
• 27 Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures, affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain pazopanib tablets.
• Malabsorption syndrome
• Major resection of the stomach or small bowel. 3.28 Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
• Active peptic ulcer disease
• Known intraluminal metastatic lesion/s with risk of bleeding
• Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
• 29 Known endobronchial lesions and or lesions infiltrating major pulmonary vessels.
• 30 Cavitary lesions deemed to be at increased risk of bleeding.
• 31 Any other severe underlying diseases that are, in the judgment of the investigator, inappropriate for entry into this study.
• 32 Second primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated ≥5 years previously with no subsequent evidence of recurrence. Patients with a history of low-grade (Gleason score ≤6) localized prostate cancer will be eligible even if diagnosed <5 years prior to registration.
• 33 Any ancillary therapy considered investigational (utilized for a non-FDA approved indication and in the context of a research investigation) ≤4 weeks prior to registration.
• 34 Other concurrent chemotherapy, immunotherapy, radiotherapy.
• 35a. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or other agents used in the study.
• b. Medications that act through the CYP450 system. Some medications that act through the cytochrome P450 system are specifically prohibited in patients receiving pazopanib. Certain other agents should be used with caution. (A list of medications that are specifically prohibited or that should be used with caution during this trial of pazopanib will be provided with the full study protocol as Appendix 1. A list of selected agents that could affect pazopanib will be listed in Appendix I. ) c. Any of the following concurrent severe and/or uncontrolled medical conditions:

Where it is running

• Illinois CancerCare, P.C. — Bloomington, Illinois, United States
• Illinois CancerCare, P.C. — Canton, Illinois, United States
• Illinois CancerCare, P.C. — Carthage, Illinois, United States
• Illinois CancerCare, P.C. — Eureka, Illinois, United States
• Illinois CancerCare, P.C. — Galesburg, Illinois, United States
• Illinois CancerCare, P.C. — Macomb, Illinois, United States
• Illinois CancerCare, P.C. — Monmouth, Illinois, United States
• Illinois CancerCare, P.C. — Normal, Illinois, United States
• Illinois CancerCare, P.C. — Ottawa, Illinois, United States
• Illinois CancerCare, P.C. — Pekin, Illinois, United States
• Illinois CancerCare, P.C. — Peoria, Illinois, United States
• Illinois CancerCare, P.C. — Peru, Illinois, United States
• Illinois CancerCare, P.C. — Princeton, Illinois, United States

Full record on ClinicalTrials.gov

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