Pazopanib for Treating Uterine Leiomyosarcoma

NCT02378142 | Withdrawn Phase 2 DMC

• 1 other identifier: GOG-3006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test any good and bad effects of the study drug pazopanib.

Conditions

Uterine Leiomyosarcoma

Outcome Measures

Primary Outcomes (2)

• Event free survival

  To estimate the proportion of patients with persistent or recurrent uterine leiomyosarcoma, who survive event-free for at least 6 months (EFS \> 6 months; events associated with the endpoint are death, disease progression, or beginning a subsequent therapy) and the proportion of patients who have objective tumor response (complete or partial), treated with pazopanib.

  6 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  To determine the nature and degree of toxicity of pazopanib in this cohort of patients

  Every 4 weeks

Secondary Outcomes (3)

• Progression-free survival

  Every 3 months from time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years

• Event-free survival

  Every 3 months from time of study entry totime of progression or death, whichever occurs first, assessed up to 5 years

• Overall survival

  Every 3 months from time of study entry totime of progression or death, whichever occurs first, assessed up to 5 years

Study Arms (1)

Arm 1

EXPERIMENTAL

Pazopanib 800mg oral daily

Drug: Pazopanib

Interventions

Pazopanib DRUG

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent or persistent leiomyosarcoma of the uterus.
• measurable disease.
• Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1 (Section 8.1).
• Patients must not be eligible for a higher priority GOG protocol, if one exists. In general, this would refer to any active GOG Phase III protocol.
• GOG Performance Status of 0, 1, or 2.
• Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Hormonal therapy will not count as a prior regimen (either cytotoxic or non-cytotoxic).
• Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration.
• Any prior radiation therapy must be completed at least 2 weeks prior to registration.
• At least 4 weeks must have elapsed since the patient underwent any major surgery (for example, hysterectomy, resection of a metastatic nodule); placement of a central venous catheter is considered minor, not major and thus time from a minor procedure until treatment on study may be shorter than 4 weeks.
• Patients must have had at least one prior chemotherapeutic regimen for management of leiomyosarcoma.
• Patients may have had one additional chemotherapeutic regimen for management of leiomyosarcoma, for a total of two prior lines of therapy.
• Patients must have NOT received any non-cytotoxic (biologic or targeted) agents as part of their primary treatment or for management of recurrent or persistent disease. (Patients who were previously treated on GOG 0250, a randomized trial of gemcitabine-docetaxel plus bevacizumab or placebo, are eligible, provided that the patient is known to have been treated on the placebo-containing arm and did not receive prior bevacizumab)
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl (1.5 x 109/L). Platelets greater than or equal to 100,000/mcl (100 x 109/L). Hemoglobin greater than or equal to 9 g/dL. Patients may not have had blood transfusion or platelet transfusion within 7 days of screening assessment.
• Creatinine less than or equal to 1.5 mg/dL (133 umol/L) or, if \>1.5 mg/dl, then calculated creatinine clearance must be greater than or equal to 30 mL/min.

You may not qualify if:

• Prior therapy with pazopanib.
• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies as noted in Sections 3.23 and 3.24, are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine leiomyosarcoma within the last three years are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine leiomyosarcoma within the last three years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
• Patient has been treated with an investigational agent or device within 30 days of entering the study.
• Patient is known to have history of active Hepatitis B or C.
• Patients with clinically significant cardiovascular disease. This includes:
• Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility. (Note: initiation of antihypertensive medications is permitted prior to study entry. At least 24 hours must have elapsed between antihypertensive medication initiation and BP measurement. At that time the BP should be measured 3 times, approximately 2 minutes apart, the 3 values should be averaged. This average or mean BP must be less than 140/90 mmHg.
• Myocardial infarction or unstable angina or cardiac angioplasty or cardiac stenting or coronary artery bypass graft surgery or symptomatic peripheral vascular disease within 6 months of the first date of pazopanib therapy.
• New York Heart Association (NYHA) Class II or greater congestive heart failure (Appendix II).
• Women who have received prior anthracycline (e.g., doxorubicin and/or liposomal doxorubicin) and who have an ejection fraction less than the institutional lower limit of normal will be excluded from the study. Patients with a prior life time exposure to doxorubicin (or liposomal doxorubicin) of greater than 300 mg/m2 are NOT eligible.
• CTCAE grade 2 or greater peripheral vascular disease.
• History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of pazopanib therapy.
• Women with a baseline QTc \>480 milliseconds.
• History of cerebrovascular accident, including transient ischemic attack, or pulmonary embolism, within the past 6 months. (Note: subjects with recent DVT only (no PE) who have been treated with therapeutic anticoagulation for at least six weeks are eligible).

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Interventions

pazopanib

Study Officials

• Martee Hensley, MD

  MSKCC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 4, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2018
• Last Updated: November 18, 2015

Record last verified: 2015-11