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Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
GlaxoSmithKline
Information provided by (Responsible Party):
Leena Gandhi, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01253369
First received: November 17, 2010
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel formation. This drug has been used in other cancer research studies and information from those studies suggests that pazopanib may help block proteins that are important for the growth, invasion, and spread of cancer cells.

In this research study, the investigators are looking:

  • To see if pazopanib can stabilize or shrink participant's tumor(s)
  • To find out if pazopanib causes changes in blood/urine proteins associated with small cell lung cancer
  • To assess the use of perfusion CT scans for determining the effect of pazopanib on the blood flow to the tumor

Condition Intervention Phase
Small Cell Lung Cancer
Lung Cancer
SCLC
Drug: Pazopanib
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: A Phase II Study of Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Progression-free rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the progression-free rate in participants with relapsed or refractory small cell lung cancer who have received 1-2 prior regimens of systemic chemotherapy at 8 weeks.


Secondary Outcome Measures:
  • Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the response rate as measured by RECIST 1.1 criteria and changes in blood flow/perfusion as measured by perfusion CT.

  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the number of Participants with Adverse Events as a Measure of Safety and Tolerability


Enrollment: 33
Study Start Date: June 2010
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pazopanib
    taken orally once a day
Detailed Description:
  • All participants will take pazopanib tablets once daily. Each treatment cycle lasts 28 days.
  • The following tests and procedures will be performed during specific time points during the research study: Clinical exams, vital signs, safety blood tests, research blood tests, electrocardiograms, research urine samples, perfusion CT scans, and assessment of the tumor(s) by x-ray, CT scans and/or MRI scans.
  • Participant's may remain in the research study as long as their cancer is not progressing and they are tolerating pazopanib.
  Eligibility

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

Inclusion Criteria:

  • Diagnosis of small cell neuroendocrine carcinoma based on either histology or cytology with radiologically-confirmed progressive disease.
  • Participants should have received first-line chemotherapy and may have had up to two prior chemotherapy regimens. Radiation therapy may have been part of the permitted prior therapy.
  • Participants with brain metastases will be allowed if they have been treated with surgery and/or radiation therapy more than 21 days prior, are asymptomatic, and are stable for at least one week off steroids.
  • 18 years of age or older
  • ECOG Performance status of 0, 1 or 2
  • Ability to swallow and retain oral medication
  • Disease must be measurable according to RECIST 1.1
  • Adequate organ function as defined in the protocol

Exclusion Criteria:

  • Prior malignancy except for participants that have been disease-free for 3 years or with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
  • History or clinical evidence of central nervous system 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 one week prior to first dose of study drug.
  • Clinically significant gastrointestinal abnormalities
  • Presence of uncontrolled infection
  • Prolongation of corrected QT interval (QTc) > 480msecs
  • History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; Class III or IV congestive heart failure
  • Poorly controlled hypertension
  • History of cerebrovascular accident including transient ischemic attack, pulmonary embolism or insufficiently treated deep venous thrombosis within the past 6 months
  • 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
  • Evidence of active bleeding or bleeding diathesis
  • Hemoptysis in excess of 2.5mL within 6 weeks of first dose of study drug
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
  • Use of any prohibited medication within the timeframes listed in the protocol
  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
  • Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors
  • Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy
  • Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
  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: NCT01253369

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Leena Gandhi, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Leena Gandhi, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01253369     History of Changes
Other Study ID Numbers: 10-125, 113115
Study First Received: November 17, 2010
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
pazopanib

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014