Sunitinib as a Second-line Treatment for Patients With Recurrent Small Cell Lung Cancer

NCT00620347 | Completed Phase 2 DMC

• 1 other identifier: NCCCTS-07-285
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

the investigators will conduct a phase II trial to evaluate the efficacy and toxicity of Sunitinib in patients with recurrent SCLC.

Conditions

Lung Cancer

Keywords

SCLC (small cell lung cancer); ED (extensive disease); RR (response rate)

Outcome Measures

Primary Outcomes (1)

• Tumor response rate

  The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria.

  at 4week and every 8 weeks

Secondary Outcomes (3)

• Overall survival

  every 8 weeks

• Progression-Free Survival

  at 4 week and every 8 weeks

• Toxicity

  every 4 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

Single arm (sunitinib arm) until PD, unacceptable toxicity, patients refused

Drug: sunitinib

Interventions

sunitinib DRUG

sunitinib (50mg/day, 4weeks on, 2 weeks off) Repeat every 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, or patients' refusal.

Single arm

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic confirmed SCLC
• Clinically diagnosed ED-SCLC according to sixth Edition of the AJCC cancer staging manual
• Progression during or after prior first line chemotherapy.
• Resolution of all acute toxic effects of prior therapy or surgical procedure to grade ≤ 1 (except alopecia)
• Prior radiation therapy excluded lung is allowed.
• No other forms of cancer therapy, such as chemotherapy, radiation, immunotherapy for at least 3 weeks before the enrollment in study.
• Performance status of 0, 1, 2 on the ECOG criteria.
• Tumor work-up: within 4weeks prior 1st day of treatment: chest X-ray; CT of chest, liver, and adrenal glands; bone scan; brain MRI
• At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors.
• Estimated life expectancy of at least 12 weeks.
• Patient compliance that allows adequate follow-up.
• Adequate organ function for chemotherapy
• Adequate cardiac function: normal EF by Echocardiography
• No ischemic heart disease or cardiac dysrhythmia.
• Normal QTc interval

You may not qualify if:

• Diagnosis of any second malignancy within the past 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence or recurrent disease for 12 months
• NCI CTCAE grade ≥ 2 neuropathy from any cause
• Ongoing treatment with therapeutic doses of coumarin derivatives, such as warfarin, (low dose Coumadin® up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed)
• Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic off steroids
• Any of the following within the 12 months prior to starting study treatment: myocardial infarction, sever/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus
• NCI CTCAE Grade 3 hemorrhage \< 4 weeks of starting study treatment
• Hypertension (\>150/100 mg Hg) that cannot be controlled with standard antihypertensive agents
• Ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval \> 450 msec for males or \> 470 msec for female
• Known human immunodeficiency virus (HIV) seropositivity
• Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrolment
• Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Pfizer: collaborator

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 411-764, South Korea

Location

Related Publications (1)

• Han JY, Kim HY, Lim KY, Han JH, Lee YJ, Kwak MH, Kim HJ, Yun T, Kim HT, Lee JS. A phase II study of sunitinib in patients with relapsed or refractory small cell lung cancer. Lung Cancer. 2013 Feb;79(2):137-42. doi: 10.1016/j.lungcan.2012.09.019. Epub 2012 Nov 20.

  PMID: 23182663 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ji-Youn Han, M.D.,Ph.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Center for Lung Cancer

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 21, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

KR (1)