None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Lapatinib, in 250 mg tablets, at a dose of 1000 mg, PO, QD + Pazopanib, in 100 mg tablets, at a dose of 400 mg, PO, QD. This scheme will continue until the progression of the disease or the appearance of unacceptable toxicity.
Group name:GROUP 3 Type of group
This group will be treated with Pazopanib, in 400 mg tablets, at a dose of 800 mg, PO, QD, until the progression of the disease or the appearance of unacceptable toxicity.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent signed before performing any procedure related to the study. 2. Female patients ≥18 years of age. 3. Life expectancy of at least 12 weeks. 4. Performance condition according to the Cooperative Group in Eastern Oncology (ECOG) in 0 or 1. 5. Cervical cancer histologically confirmed in stage IVB according to FIGO, or squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the recurrent or persistent cervix that is not amenable to a curative treatment with surgery and / or radiation therapy. 6. Measurable disease. 7. At least one white lesion. 8. Not having received any chemotherapy regimen or having received a chemotherapy regimen previously for metastatic disease. 9. Having recovered from the effects of surgery or chemotherapy. 10. Proper functioning of the organs and bone marrow. 11. Ability to swallow and retain medication administered orally. 12. A woman is eligible to enter and participate in the present study if: a) She is not able to have family. b) Being able to have a family, has a negative result in a serum test to diagnose pregnancy within 2 weeks prior to receiving the first dose of study medication and agrees to use adequate contraception during their participation in the study; and for a minimum of 2 menstrual cycles after receiving the last dose of study medication. 13. Patients must complete all screening evaluations, as outlined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Neuroendocrine carcinoma or carcinoma of the small cell cervix. 2. Previous use of some biological therapy with inhibitors of VEGF, VEGFR or ErbB2 / ErbB2 receptors. 3. Concurrent therapy against cancer. 4. Concurrent treatment with an agent in research or participation in another clinical trial. 5. Use of a cancer research drug within 28 days or for 5 half-lives, whichever is longer, before the first dose of study medication is given. 6. Have taken or are taking prohibited medications. 7. Any other serious and / or unstable medical, psychiatric, or any other condition that could interfere with the patient´s safety. 8. History of another malignancy. 9. History or clinical evidence of metastasis in the central nervous system or with leptomeningeal carcinomatosis. 10. Malabsorption syndrome, a disease that significantly affects gastrointestinal functioning or gastric or small bowel resection. 11. Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition that increases the risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 4 weeks before starting therapy. 12. Presence of an uncontrolled infection. 13. Reactions of immediate, delayed hypersensitivity known, or idiosyncratic to drugs chemically related to pazopanib. 14. Prolongation of the corrected QT interval (QTc). 15. History of any of the following cardiac conditions in the last 6 months: a) Cardiac angioplasty or placement of a cardiac implant (stent). b) Myocardial infarction. c) Unstable angina. 16. History of a stroke or pulmonary embolism in the last 6 months. 17. With heart failure of functional grades III or IV. 18. Poorly controlled hypertension. 19. History of deep vein thrombosis (DVT) not treated during the last 6 months. 20. Presence of any wound, fracture, or ulcer that does not heal, or the presence of symptomatic peripheral vascular disease. 21. Patients with bilateral hydronephrosis that can not be relieved by the placement of ureteral implants (stents) or percutaneous drainage. 22. A major surgical procedure, an open biopsy or a significant traumatic injury within 4 weeks prior to initiating therapy, or anticipating the need to undergo a major surgical procedure during the course of the study; It also excludes patients who undergo minor surgical procedures. 23. Inability to swallow and retain medication administered orally. 24. Pregnant woman or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of the time from the start of the medication to the progression, defined as: 1) Increase by at least 20% in the sum of the largest diameters of white lesions. 2) Occurrence of 1 or more injuries and / or unambiguous progression of non-white lesions. The lesions should be confirmed with CT, MRI and / or biopsy. Measure:Free Survival of Progression. Timepoints:At 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Evaluation of the time from randomization to death for any reason or even loss of contact. Criterion 2: Clinical evaluation, to determine compliance with the criteria of complete response (CR) or partial response (RP) or stable disease (SD) for 6 months. Where RC is the disappearance of all white and non-white lesions. The RP is the decrease in at least 30% of the sum of the largest diameter of all white lesions. The SD is that disease that does not meet criteria of progression or response. The lesions should be confirmed with CT, MRI and / or biopsy. Criterion 3: Based on the RECIST criteria. Criteria 4 and 5: Time to reach the response criteria (defined above) and duration of these. Measure:1) General survival. 2) Clinical benefit. 3) General response index. 4) Time until the answer. 5) Duration of the response. Timepoints:At 52 weeks. ; Outcome name:Criterion 1: Medical evaluation of any medical event in a patient to whom the study drug was administered, whether or not it has a causal relationship with it. Criterion 2: Determination of height, body weight, evaluation of patient conditions. Criterion 3: Blood pressure after 10 minutes of sitting and body temperature Criterion 4: 12-lead electrocardiogram, with special emphasis on the QTc interval. Criterion 5: Panels of hematology, serum and coagulation chemistry, urine tests. Measure:Safety and tolerability: 1) Adverse events (AD). 2) Physical examination. 3) Vital signs. 4) ECG. 5) Laboratory tests. Timepoints:1) Adverse events (AEs), physical exam: Day 1 and week 3. 2) Vital Signs: Days 1 and 8. Week 3 and thereafter every 3 weeks. 4) ECG: Week 3 and thereafter every 9 weeks. 5) Laboratory tests: Before the start of treatment, day 8 and every 3 weeks. | — |
Countries
Argentina, Belgium, Canada, Estonia, France, Germany, India, Ireland, Italy, Mexico, Peru, Spain, Thailand, United States
Outcome results
None listed