Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

It has been shown in previous studies that the ability to treat lung cancer could be significantly improved by not only targeting the tumor cells directly with chemotherapy, but also by cutting off the blood supply to the cancer cells. Blood vessels that supply the tumor are formed through a process called angiogenesis. Vandetanib is an investigational drug that acts by producing what is called an anti-angiogenic effect. An Anti-angiogenic effect is able to inhibit the development of new blood vessels required by tumors to survive by blocking the growth factors needed to form new blood vessels.

The purpose of this study is to determine if the addition of vandetanib to a standard chemotherapy regimen will slow or stop the growth of the cancer for a longer period of time compared to the time period generally gained from the use of standard chemotherapy alone

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PrECOG, LLC.
• Collaborator: AstraZeneca
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer

• Advanced disease (stage IIIB disease [malignant pleural or pericardial effusion seen on CT or Chest X-ray, any N, M0] or stage IV disease [Any T, any N, M1: distant metastases]) that is primary or recurrent

• Measurable disease according to the RECIST criteria

• ECOG Performance Status 0 or 1

• Adequate organ function, as evidenced by ALL the following

• Absolute neutrophil count (ANC) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 gm/dL

• Total bilirubin ≤ 1 X institutional ULN; if patient has Gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin ≤ 2 X institutional ULN.

• AST, ALT and alkaline phosphatase (Alk Phos) must be ≤ 1.5 ULN

• Creatinine ≤ 1.5 X institutional ULN or calculated creatinine clearance ≥ 60 ml/min

• Potassium between 4 mEq/L and institutional ULN (supplementation may be used),

• Calcium (ionized or adjusted for albumin)within institutional normal limits

• Magnesium within institutional normal limits (supplementation may be used)

• No prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (Prior adjuvant therapy for lung cancer allowed if completed > 1 year prior to registration)

• Able to take oral medication

Exclusion Criteria:

• Myocardial infarction, superior vena caval syndrome, NYHA classification of heart disease ≥ 2 within the 3 months prior to entry

• History of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment

• Hypertension not controlled by medication

• Peripheral or sensory neuropathy > grade 1

• Known hypersensitivity to carboplatin or docetaxel

• Active infection