Pazopanib in Combination With Interferon Alfa 2-A, in Patients With Advanced Renal Cell Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Spanish Oncology Genito-Urinary Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier:
NCT01513187
First received: January 10, 2012
Last updated: January 16, 2012
Last verified: April 2010
  Purpose

Phase I / II, open, prospective, multicenter single-arm, Clinical Trial in two stages: in the first stage it will determine the optimal dose of the combination of pazopanib and interferon alfa-A2 in the treatment of patients with advanced renal carcinoma and a second stage that will determine the efficacy of this combination measured in terms of response rate.


Condition Intervention Phase
Advanced Renal Cell Carcinoma
Drug: Pazopanib + interferon alpha 2A
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Prospective, Open Label and Multicentric Clinical Trial to Determine the Recommended Dose (Phase I) and Efficacy of Pazopanib in Combination With Interferon Alfa 2-A (Phase II), in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Spanish Oncology Genito-Urinary Group:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) - Phase I [ Time Frame: Up to September 2012 ] [ Designated as safety issue: Yes ]
    The MTD is defined as the dose at wich two of the patients have experienced dose-limiting toxicity.

  • Efficacy, response rate (Phase II) [ Time Frame: Up to July 2013 ] [ Designated as safety issue: No ]
    Response rate is defined as the percentage of patients with complete response or partial response confirmed according RECIST v.1.1


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Up to July 2013 ] [ Designated as safety issue: No ]
    Period between the start of treatment until the day in in wich the progression is confirmed by RECIST guidelines (version 1.1) or death from any cause.

  • Overall Survival [ Time Frame: Up to December 2013 ] [ Designated as safety issue: No ]
    Period between the start of treatment and date of death from any cause.

  • Toxicity [ Time Frame: Up to July 2013 ] [ Designated as safety issue: Yes ]
    Toxicity evaluation of the combination using the NCI-CTC Criteria version 3.0

  • Translational Substudy [ Time Frame: Up to December 2013 ] [ Designated as safety issue: No ]
    To analyze the different biomarkers and their variations with clinical outcomes of patients.


Estimated Enrollment: 57
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib + interferon

Five levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days.

Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient

Drug: Pazopanib + interferon alpha 2A

Five levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days.

Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Age ≥ 18 years.
  3. Patients diagnosed histologically clear cell carcinoma of the kidney metastatic or unresectable locally advanced, previously untreated. However, in Phase I may include patients with primary tumors other than renal cell can benefit from these drugs and patients with renal cell carcinoma treated before.
  4. Performance status (ECOG) 0-1.
  5. Patients must have measurable disease by RECIST criteria V 1.1. Progression should be documented in the two months prior to study entry.
  6. Patients may not have received prior treatment with anti-VEGF agents, mTOR inhibitors or cytokines. However, in Phase I may include patients who have received any previous treatment.
  7. Paraffin tumor sample should be available and collection of serum from all subjects for biomarker analysis previously and / or during treatment with study medication.
  8. Adequate Hematologic, liver and kidney functions.
  9. Women of childbearing potential must be using an effective method of birth control (abstinence, any intrauterine device [IUD] published data showing that the expected minimum rate of failure is less than 1% per year, or any other method the published data show that the expected minimum rate of failure is less than 1% per year) before inclusion in the study and continue using it during the same six months after completion. Women of childbearing age should get a negative pregnancy test in urine or serum (minimum sensitivity 25 IU / L or equivalent units of beta fraction of human chorionic gonadotropin [β-HCG]) during the seven days prior to the randomization.
  10. Able to swallow oral compound.
  11. Willingness and ability to attend scheduled visits, to follow the treatment schedule and to undergo clinical trials and other study procedures

Exclusion Criteria:

  1. History of prior malignancies diagnosed or treated over the past 5 years except basal cell skin cancer or prostate cancer incidentally detected previously treated. However, patients with a history of malignancy but free of the disease over the past 5 years, or patients with a history of nonmelanoma skin carcinoma-completely-resected or carcinoma in situ treated successfully can participate in the study .

    In Phase I, patients diagnosed with other previous or concomitant malignant diseases can be included.

  2. Presence of metastases in the central nervous system (CNS) or leptomeningeal carcinomatosis, except for patients with previously treated CNS metastases, asymptomatic and have not needed corticosteroids or anticonvulsant drugs in the 3 months prior to administering the first dose of the drug under study. Only is required CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) if clinically indicated or if the individual has a history of CNS metastases.
  3. Clinically significant gastrointestinal disorders may increase the risk of gastrointestinal bleeding including, but not limited to:

    Active peptic ulcer disease Known metastatic lesions with probable intraluminal bleeding Inflammatory bowel disease (ulcerative colitis, Crohn's disease) or other gastrointestinal disorders with increased risk of perforation History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the start of study treatment.

  4. Clinically significant gastrointestinal abnormalities may affect the absorption of the investigational product such as but not limited to:

    Malabsorption syndrome Major resection of the stomach or small intestine Grade 3 diarrhea

  5. Patients with active infection or other disease or serious medical condition.
  6. Prolongation of the corrected QT wave (QTc)> 480 ms on baseline ECG according to the Bazett formula.
  7. Subjects with a history of one or more of the following cardiovascular disease in the last 6 months prior to the inclusion in the study:

    Angioplasty or stent placement Myocardial infarction Unstable Angina Coronary bypass surgery Symptomatic peripheral vascular disease Congestive heart failure Class II, III or IV New York Heart Association (NYHA)

  8. Poorly controlled hypertension [defined as systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure stress (DBP) ≥ 90 mmHg] while the patient is on antihypertensive therapy.

    Note: the commencement or adjustment of antihypertensive medication it is possible before the patient study start. In the baseline period measure blood pressure at least twice with a minimum interval of 24 hours. The mean values ​​of SBP / DBP in each blood pressure reading should be <140/90 mmHg to include the subject in the study.

  9. Background, in the last six months prior to the inclusion of stroke (including transient ischemic attacks), pulmonary embolism or deep vein thrombosis (DVT) untreated.

    Note: may be included subjects with recent DVT who received anticoagulants for at least 6 months.

  10. Surgery or trauma in the last 28 days, or minor surgery (eg., Removal of central venous catheter) in the last 7 days prior to inclusion or unhealed wound, fracture, or ulcer.
  11. Evidence of active bleeding or bleeding diathesis.
  12. Hemoptysis within 6 weeks prior to inclusion.
  13. Pregnant or breastfeeding.
  14. Any medical condition (eg. Uncontrolled infection), psychiatric or other to be serious and / or unstable and may interfere with the safety of the patient, obtaining informed consent or compliance with study procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513187

Contacts
Contact: Xavier García del Muro, MD +349343444112 ext 115 investigacion@mfar.net
Contact: Anna de Prado, Biologist +34934344412 ext 115 anna.deprado@mfar.net

Locations
Spain
Instituto Catalán de Oncología, Hospitalet del Llobregat Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08097
Contact: Anna de Prado, Biologist    +934344412 ext 115    anna.deprado@mfar.net   
Principal Investigator: Xavier García del Muro, MD         
Centro Integral Oncológico Clara Campal Recruiting
Sanchinarro, Sanchinarro - Madrid, Spain, 28050
Contact: Anna de Prado, Biologist    +34934344412 ext 115    anna.deprado@mfar.net   
Principal Investigator: Ignacio Durán, MD         
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
GlaxoSmithKline
Investigators
Principal Investigator: Xavier García del Muro, MD Instituto Catalán de Oncología, Hospitalet del Llobregat
  More Information

No publications provided

Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT01513187     History of Changes
Other Study ID Numbers: SOGUG-2010-01
Study First Received: January 10, 2012
Last Updated: January 16, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Keywords provided by Spanish Oncology Genito-Urinary Group:
Advanced renal cell carcinoma
SOGUG
Pazopanib
Pazopanib in combination with interferon alpha 2A

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 20, 2014