Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Recurrent Non-Small Cell Lung Carcinoma, Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IV Non-Small Cell Lung Cancer AJCC v7

In brief

This randomized phase II trial studies pemetrexed disodium and sunitinib malate to compare how well they work when given alone or together as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether pemetrexed disodium and sunitinib malate are more effective when given alone or together in treating non-small cell lung cancer.

Key facts

Study ID

NCT00698815

Run by

National Cancer Institute (NCI)

People needed

130

Starts

2008-04-15

Last updated by the study team

2022-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic documentation: histologic or cytologic documentation of NSCLC
• Stage: IIIB/IV with evidence of disease progression following first-line therapy
• Tumor site: lung (non-small cell)
• No cavitary lesions
• Only one prior chemotherapy regimen in the first-line stage IIIB/IV setting is allowed; this could have been either a platinum- or non-platinum-based regimen
• First-line therapy must be completed >= 28 days before registration
• Prior adjuvant therapy is allowed provided the patient had one previous regimen in the advanced stage IIIB/IV setting
• At least 28 days from prior major surgery and at least 14 days from any prior radiotherapy before registration
• No prior inhibitors of VEGF receptor (VEGFR) (e.g., SU5416, SU6668, AZ6474, SU11248, PTK787, AZD2171, AEE-788, sorafenib); prior treatment with epidermal growth factor receptor (EGFR) inhibitors and bevacizumab is allowed, provided at least 4 weeks has elapsed
• No prior pemetrexed
• Patients must have measurable or non-measurable disease
• Measurable disease
• Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
• Non-measurable disease
• All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions
• Lesions that are considered non-measurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Lymphangitis cutis/pulmonis
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Pregnant or nursing mothers are not eligible for this study; patients in their child bearing years must have a baseline negative pregnancy test (in the case of females); males and females must practice appropriate contraceptive measures during the period of protocol therapy and for 6 months after completion of protocol therapy; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)

Where it is running

• Arroyo Grande Community — Arroyo Grande, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Kaiser Permanente Hospital — Fontana, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Kaiser Permanente-Cadillac — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• El Camino Hospital — Mountain View, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Hematology and Oncology Associates-Oakland — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• Kaiser Permanente - Panorama City — Panorama City, California, United States
• PCR Oncology — Pismo Beach, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.