Pazopanib Hydrochloride in Treating Patients With Stage IV Kidney Cancer

NCT01157091 | Completed Phase 2 Results DMC

• 2 other identifiers: 10030NCI-2010-01497
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating patients with stage IV kidney cancer.

Conditions

Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Confirmed Response Rate (Complete Response and Partial Response) as Assessed by RECIST 1.1 Criteria

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR.

  1 year post treatment

Secondary Outcomes (2)

• Progression-free Survival

  1 year post treatment

• Overall Survival

  1 year post treatment

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: pazopanib hydrochloride; Other: laboratory biomarker analysis; Other: immunologic technique

Interventions

pazopanib hydrochloride DRUG

Given orally

Also known as: GW786034, Votrient

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

immunologic technique OTHER

Correlative studies

Also known as: immunological laboratory methods, laboratory methods, immunological

Arm I

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of metastatic clear cell RCC
• At least one measurable lesion at baseline as per RECIST 1.1 criteria; if skin lesions are reported as target lesions, they must be documented (at baseline and at every physical exam) using color photography and a measuring device (such as a caliper) in clear focus to allow the size of the lesion to be determined from the photograph
• prior VEGF-TKI required
• other prior systemic therapy allowed
• ECOG PS 0-1
• Resolution of grade \>= 2 toxicity from prior therapy
• 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
• A female is eligible to enter and participate in this study if she is of non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had (1) a hysterectomy, (2) a bilateral oophorectomy (ovariectomy), (3) a bilateral tubal ligation, or (4) 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
• Patients with childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks 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 follows: (1) complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product, (2) oral contraceptive, either combined or progestogen alone, (3) injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year, (4) male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject, (6) double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
• Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L
• Hemoglobin \>= 9 g/dL (5.6 mmol/L)
• Platelets \>= 100 X 10\^9/L
• Prothrombin time (PT) or international normalized ratio (INR) =\< 1.2 X ULN
• Activated partial thromboplastin time (aPTT) =\< 1.2 X ULN
• Total bilirubin =\< 1.5 X ULN

You may not qualify if:

• Concurrent use of other investigational agents
• Known history of allergic reactions to pazopanib or other VEGF-TKIs
• Presence of serious or uncontrolled infection
• Prior malignancy (Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects 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, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug; screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to (1) active peptic ulcer disease, (2) known intraluminal metastatic lesion/s with risk of bleeding, (3) inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), (4) other gastrointestinal conditions with increased risk of perforation, or (5) 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 (1) malabsorption syndrome or (2) 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 6 months: (1) cardiac angioplasty or stenting, (2) myocardial infarction, (3) unstable angina, (4) coronary artery bypass graft surgery, (5) symptomatic peripheral vascular disease, or (6) Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
• 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
• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; (Note: subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible)
• Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
• Evidence of active bleeding or bleeding diathesis
• Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (2)

City of Hope

Duarte, California, 91010, United States

Location

South Pasadena Cancer Center

Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib; Immunologic Techniques

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Sumanta Pal
• Organization: City of Hope

SPal@coh.org

626-359-8111

Study Officials

• Sumanta Pal

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: December 8, 2010
• Primary Completion: October 17, 2013
• Study Completion: December 31, 2013
• Last Updated: June 8, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-05

Locations

US (2)