A Phase I Trial of SS1 (dsFv) PE38 With Paclitaxel, Carboplatin, and Bevacizumab in Subjects With Unresectable Non-Small Cell Lung Adenocarcinoma

Completed · Phase 1

Conditions studied: Non-Small Cell Lung Cancer, Adenocarcinoma

In brief

Background: * Advanced cases of non-small-cell lung carcinoma (NSCLC) usually are not successfully treated with standard therapies. Even treatments that attempt to specifically target NSCLC cells have not proved effective. * Researchers are interested in determining whether a combination of the chemotherapy drugs SS1 (dsFv) PE38, paclitaxel, carboplatin, and bevacizumab may be effective in shrinking the size of NSCLC tumors. Three of the drugs (paclitaxel, carboplatin, and bevacizumab) are commercially available, while the other is a drug that is currently being tested to determine its usefulness in cancer treatment. This study will help to determine if the combination of all four drugs is more effective and as safe, safer, or less safe than other drug combinations given to treat NSCLC. Objectives: \- To determine a safe and tolerable dose for the combination of SS1 (dsFv) PE38 with paclitaxel, carboplatin, and bevacizumab in patients with advanced mesothelin-expressing lung adenocarcinoma. Eligibility: * Age \> 18 years of age * Newly diagnosed advanced non-small-cell lung carcinoma * No prior chemotherapy for lung cancer * Individuals at least 18 years of age who have advanced non-small-cell lung carcinoma that has not responded to standard treatments. Design: * The study will last for two 21-day cycles of treatment for the four-drug combination, with additional treatment cycles of carboplatin, paclitaxel, and bevacizumab. * Two to three weeks prior to the study, participants will be screened with a full medical history and physical exam, bone marrow biopsy (we do not do bone marrow biopsies) (if one has not been performed in the last 6 months), computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as required by the researchers. Participants will provide blood and urine samples at this time as well. * During the study, participants will receive SS1 (dsFv) PE38, carboplatin, paclitaxel, and bevacizumab for a maximum of two cycles. On Day 15 of the first cycle, participants will provide a blood sample to be tested to see if SS1 (dsFv) PE38 is being effective. If the tests show that SS1 (dsFv) PE38 is not effective, participants will not receive another dose of it, but will continue to receive paclitaxel, carboplatin, and bevacizumab for the second cycle. * After the first two cycles, participants will continue to receive carboplatin, paclitaxel, and bevacizumab every 3 weeks for up t...

Key facts

Study ID

NCT01051934

Run by

National Cancer Institute (NCI)

People needed

2

Starts

2009-12-29

Expected to finish

2011-09-28

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Squamous cell cancer or mixed tumors with any small cell element.
• Tumor of any histology in close proximity to a major vessel or cavitation.
• History of hemoptysis (bright red blood of teaspoon or more (greater than or equal to 2.5 mL)) on one occasion unrelated to any diagnostic procedure within the past year.
• Patients with CNS metastases.
• History of uncontrolled hypertension, defined as blood pressure > 140/90 mmHg (NCI CTEP Active Version of the CTCAE grade greater than or equal to 2) are excluded. However, these patients will be eligible if the blood pressure is < 140/90 mmHg after anti-hypertensive treatment.
• Any of the following within 6 months prior to study enrollment: myocardial infarction, unstable angina pectoris or uncontrolled angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, clinically significant peripheral vascular disease (Grade II or greater). History of stroke or transient ischemic attack within 6 months.
• Psychiatric or neurologic illness that would limit compliance with study requirements.
• Patients with serious illness or medical condition.
• Severe active infection within 14 days requiring use of intravenous antibiotics before beginning treatment.
• Patients may not be receiving any other investigational agents.
• History of an active malignancy unless curatively treated and risk of recurrence of < 5% at five years other than in situ carcinoma of the cervix, or non-melanomatous skin cancers.
• Patients must not be on therapeutic anticoagulation, chronic daily treatment with aspirin 325mg/day or non steroidal anti-inflammatory agents, or any agent known to inhibit platelet function, within 10 days prior to day 1 on study. Low dose aspirin 81mg/day is allowed.
• History of pulmonary embolism, deep venous thrombosis or other thromboembolic event within 6 months.
• Patients with a history of severe hypersensitivity reaction to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, bevacizumab or other agents used in the study.
• History of a major surgical procedure, open biopsy, or a significant traumatic injury within 35 days prior to commencing treatment, or the anticipation of the need for a major surgical procedure during the course of the study prior to the predetermined date of tumor excision. Fine needle aspirations or core biopsies within 7 days prior to commencing treatment are allowed.
• History of abdominal fistula, gastrointestinal perforation, intra- abdominal abscess or tracheo-esophageal fistula.
• Non-healing wound or ulcer.
• Evidence of coagulopathic disorder or hemorrhagic diathesis. INR greater than 1.5.
• Pregnancy (positive pregnancy test) or active breast feeding.
• Urine protein: creatinine ratio greater than or equal to 1.0 at screening.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
• Significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, 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.