Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas

Completed · Phase 2

Conditions studied: Adult Liposarcoma, Metastatic Liposarcoma, Metastatic Osteosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Liposarcoma, Recurrent Osteosarcoma, Stage IV Adult Soft Tissue Sarcoma

In brief

The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The safety of this drug combination will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT02357810

Run by

Northwestern University

People needed

178

Starts

2015-03-21

Expected to finish

2021-10-12

Last updated by the study team

2022-06-07

Who can join

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

You may qualify if…

• Patients 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
• Patients must have a histologically confirmed diagnosis of:
• Metastatic soft tissue sarcomas (non-liposarcoma)
• Metastatic osteosarcoma
• Metastatic liposarcoma- high grade, de-differentiated, or myxoid Note: pathology is not required to be reviewed at the treating institution; a copy of the pathology report is sufficient for eligibility purposes
• Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patients must have measurable disease within 4 weeks prior to registration by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10mm with spiral computed tomography (CT) scan
• Patients must have had a minimum of 1 and a maximum of 4 prior chemotherapy regimens for recurrent/metastatic disease; it will be up to the investigator to determine what constitutes a "regimen" in each case; the last dose of systemic therapy much have been given at least 4 weeks prior to initiation of therapy; patients receiving BCNU or mitomycin C must have received their last dose at least 6 weeks prior to initiation of therapy
• Patients with brain metastasis are eligible for participation only if they have been treated with definitive surgery or radiation (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 12 week interval
• Absolute neutrophil count (ANC) >= 1.5 X 10\^9/L (tested within 7 days prior to Registration)
• Hemoglobin >= 9 g/dL (5.6 mmol/L)
• Subjects may not have had a transfusion within 7 days of screening assessment
• Platelets >= 100 X 10\^9/L
• Subjects may not have had a transfusion within 7 days of screening assessment
• Prothrombin time (PT) or international normalized ratio (INR) =< 1.2 X upper limit of normal (ULN)
• Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation
• Activated partial thromboplastin time (aPTT) =< 1.2 X ULN
• Total bilirubin =< 1.5 X ULN
• Alanine amino transferase (ALT) and aspartate aminotransferase (AST) =< 2.5 X ULN
• Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN (upper limit of normal) are not permitted
• Serum creatinine =< 1.5 mg/dL (133 umol/L) or, if > 1.5 mg/dL: calculated creatinine clearance (ClCR) >= 30 mL/min to >= 50 mL/min
• Urine protein to creatinine ratio (UPC) < 1
• If UPC >= 1, then a 24-hour urine protein must be assessed; subjects must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable
• Females of child-bearing potential (FOCBP) and males must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days following completion of therapy; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; Note: a FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy

You may not qualify if…

• Patients with any of the following sarcoma histologic subtypes will not be eligible for participation:
• Alveolar soft-part sarcoma
• Chondrosarcoma
• Dermatofibrosarcoma
• Ewing sarcoma
• Gastrointestinal stromal tumor (GIST)
• Kaposi sarcoma (non-human immunodeficiency virus [HIV] and HIV related disease)
• Mixed mesodermal tumor/carcinosarcoma
• Low grade (grade 1) sarcomas
• Rhabdomyosarcoma (embryonal, alveolar, pleomorphic)
• Interdigitating dendritic sarcoma
• Giant cell tumor of the bone
• Patients must not have received prior treatment with pazopanib or topotecan
• Patients must not have an active secondary malignancy
• Prior malignancy, unless they have been disease-free for 3 years, or have a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
• 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
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel
• Corrected QT interval (QTc) > 480 msecs using Bazett's formula
• History of any one or more of the following cardiovascular conditions within the past 12 months:

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Northwestern University- Lake Forest Hospital — Lake Forest, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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