Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer

Completed · Phase 2

Conditions studied: Neoplasms, Uterine Cervix, Metastatic Cervical Cancer

In brief

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

Key facts

Study ID: NCT00430781
Run by: GlaxoSmithKline
People needed: 228
Starts: 2006-11-01
Expected to finish: 2011-07-01
Last updated by the study team: 2015-05-08

Who can join

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

You may qualify if…

A subject will be eligible for inclusion in this study only if all of the following criteria are met:
Signed, written informed consent prior to performing any study-related procedures
Female subjects ≥18 years of age
FIGO Stage IVB, or recurrent or persistent cervical cancer
Life expectancy of at least 12 weeks
ECOG status of 0 or 1.
Histologically confirmed FIGO Stage IVB, or recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpitation, plain x-ray, CT and MRI, or ≥10 mm when measured by spiral CT.
At least one "target lesion" to be used to assess response as defined by Response Evaluation Criteria in Solid Tumors (RECIST; Terasse, 2000). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
Received 0 or 1 prior chemotherapy regimen for metastatic disease.
Note: Chemotherapy given in combination with radiation therapy as a radiosensitizer does not count toward this prior therapy limit
Recovered from the effects of surgery or chemotherapy. At least three weeks must have elapsed from the last administration of chemotherapy.
Adequate organ and bone marrow function as defined in Table 1.
Table 1:(Definitions for Adequate Organ Function)
System:(Laboratory Values)
Hematologic: Absolute neutrophil count (ANC)(≥ 1.5 X 109/L)Hemoglobin1(≥9 g/dL)Platelets(≥100 X 109/L)
Hepatic: Total bilirubin (≤1.5 X ULN)AST and ALT (≤2.5 X ULN)
Renal: Calculated creatinine clearance2 (≥50 mL/min)
Urine protein3 (Negative, trace or +1 by dipstick urinalysis or <1.0 gram determined by 24 hour urine protein analysis.)
Subjects may not have had a transfusion within 7 days of screening assessment.
Calculated by Cockcroft Gault formula See Appendix 7: Renal Function Tests
A patient should first be screened with dipstick urinalysis. If urine protein by dipstick analysis is ≥2+, then a 24-hour urine protein must be assessed and 24 hour urine protein must be <1 g protein to be eligible.
Ability to swallow and retain oral medication.
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:

You may not qualify if…

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Neuroendocrine or small cell carcinoma of the cervix.
Prior use of any biologic therapy with VEGF, VEGFR, or ErbB1/ErbB2 inhibitors.
Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
Concurrent treatment with an investigational agent or participation in another clinical trial.
Use of an investigational anti-cancer drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
Has taken or is taking prohibited medications listed in the protocol.
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 5 years, or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated.
Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
Presence of uncontrolled infection.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs.
History of any one of the following cardiac conditions within the past 6 months:
Cardiac angioplasty or stenting
Myocardial infarction
Unstable angina
History of cerebrovascular accident or pulmonary embolus within the past 6 months.
Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (See Appendix 6)
Poorly controlled hypertension (systolic blood pressure (SBP) of ≥ 140mmHg, or diastolic blood pressure (DBP) of ≥ 90mmHg).
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP/DBP values from both BP assessments must be < 140/90mmHg in order for a subject to be eligible for the study.
History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. calf vein thrombosis).
Note: Patients with recent DVT who are treated with therapeutic anti-coagulant agents (excluding therapeutic warfarin) for at least 6 weeks are eligible.

Where it is running

GSK Investigational Site — Orange, California, United States
GSK Investigational Site — Stanford, California, United States
GSK Investigational Site — Augusta, Georgia, United States
GSK Investigational Site — Boston, Massachusetts, United States
GSK Investigational Site — Albuquerque, New Mexico, United States
GSK Investigational Site — New York, New York, United States
GSK Investigational Site — Cleveland, Ohio, United States
GSK Investigational Site — Columbus, Ohio, United States
GSK Investigational Site — Oklahoma City, Oklahoma, United States
GSK Investigational Site — Chattanooga, Tennessee, United States
GSK Investigational Site — Dallas, Texas, United States
GSK Investigational Site — Capital Federal, Buenos Aires, Argentina
GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site — Neuquén, Neuquén Province, Argentina
GSK Investigational Site — Rosario, Santa Fe Province, Argentina
GSK Investigational Site — Santa Fe, Santa Fe Province, Argentina
GSK Investigational Site — San Miguel de Tucumán, Tucumán Province, Argentina
GSK Investigational Site — Quilmes, Argentina
GSK Investigational Site — Brussels, Belgium
GSK Investigational Site — Brussels, Belgium
GSK Investigational Site — Ghent, Belgium
GSK Investigational Site — Leuven, Belgium
GSK Investigational Site — Roeselare, Belgium
GSK Investigational Site — Calgary, Alberta, Canada
GSK Investigational Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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