Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer

NCT01253369 | Completed Phase 2 Results DMC

• 2 other identifiers: 10-125113115
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Small Cell Lung Cancer; Lung Cancer; SCLC

Keywords

pazopanib

Outcome Measures

Primary Outcomes (1)

• 8-Week Progression-Free Rate

  The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions.

  For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).

Secondary Outcomes (1)

• Objective Response Rate

  Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).

Study Arms (1)

Pazopanib

EXPERIMENTAL

Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.

Drug: Pazopanib

Interventions

Pazopanib DRUG

Also known as: Votrient

Pazopanib

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• GlaxoSmithKline: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Gandhi L; Heist RS; Lucca JV; Temel JS; Fidias P; Morse LK; Johnson BE; Dana-Farber Cancer Institute, Boston, MA; Massachusetts General Hospital Cancer Center, Boston, MA. A phase II trial of pazopanib in relapsed/refractory small cell lung cancer (SCLC). J Clin Oncol 2012; 30 (suppl; abstr 7099)

  RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: David Jackman, MD
• Organization: Dana-Farber Cancer Institute

DJACKMAN@PARTNERS.ORG

617-632-6049

Study Officials

• David Jackman, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: December 3, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2014
• Last Updated: April 23, 2019
• Results First Posted: January 12, 2016

Record last verified: 2019-04

Locations

US (3)