Track topics on Twitter Track topics that are important to you
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib 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. Giving combination chemotherapy together with radiation therapy and vandetanib may kill more tumor cells.
PURPOSE: This randomized phase I/II trial is studying the side effects of giving paclitaxel, carboplatin, and high-dose radiation therapy with or without vandetanib and to see how well it works in treating patients with stage IIIA or stage IIIB non-small cell lung cancer.
- To determine the median survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel, carboplatin, and high-dose radiotherapy with or without vandetanib.
- To determine the overall response rate and failure-free survival of patients treated with these regimens.
- To determine the feasibility of concurrent vandetanib and chemoradiotherapy as measured by safety and compliance.
- To correlate outcomes (survival, toxicity, and quality of life) with biological parameters.
OUTLINE: This is a multicenter, phase I study followed by a phase II randomized study.
- Phase I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly and oral vandetanib once daily for 7 weeks. Patients also undergo high-dose radiotherapy once daily 5 days a week for 7 weeks. Beginning in week 11, patients receive consolidation therapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks and oral vandetanib once daily for 6 weeks. Beginning in week 20, patients receive maintenance therapy comprising oral vandetanib once daily for 2 years.
- Phase II: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel and carboplatin and undergo high-dose radiotherapy as in phase I. Patients also receive oral placebo once daily for 7 weeks. Beginning in week 11, patients receive consolidation therapy comprising paclitaxel and carboplatin as in phase I and oral placebo once daily for 6 weeks. Beginning in week 20, patients receive maintenance therapy comprising oral placebo once daily for 2 years.
- Arm II: Patients receive treatment as in phase I. After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, and then every 6 months for 2 years.
Allocation: Randomized, Primary Purpose: Treatment
carboplatin, paclitaxel, vandetanib, placebo, radiation therapy
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:19:24-0400
RATIONALE: Vandetanib 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. Drugs used in chemotherapy, such as...
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high...
This phase I trial studies the side effects, best dose, and best way to give pembrolizumab when given together with paclitaxel, carboplatin, and radiation therapy in treating patients with...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by sto...
The goal of this clinical research study is to learn about the safety of adding MDPL3280A to standard chemotherapy (a combination of carboplatin and paclitaxel) and radiation in patients w...
Nab-paclitaxel maintenance therapy following carboplatin + nab-paclitaxel combination therapy in chemotherapy naïve patients with advanced non-small cell lung cancer: multicenter, open-label, single-arm phase II trial.
Background A global multicenter study demonstrated superiority of carboplatin + nab-paclitaxel (PTX) therapy compared to carboplatin + PTX in terms of response rate (RR) and non-inferiority in terms o...
We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC METHODS: In an open-l...
The carboplatin/paclitaxel doublet remains the chemotherapy backbone for the initial treatment of ovarian cancer. This two-drug regimen, with carboplatin dosed using the Calvert formula, yielded convi...
The objectives of this study were to assess the feasibility of preoperative gemcitabine/nab-paclitaxel-based chemoradiation therapy (CRT) for patients with borderline resectable pancreatic cancer (BRP...
Small cell lung cancer (SCLC) is a very aggressive form of lung cancer. SCLC treatment requires multidisciplinary management and timely treatment. Radiation therapy is an important part of management ...
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.
Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.
A performance measure for rating the ability of a person to perform usual activities, evaluating a patient's progress after a therapeutic procedure, and determining a patient's suitability for therapy. It is used most commonly in the prognosis of cancer therapy, usually after chemotherapy and customarily administered before and after therapy. It was named for Dr. David A. Karnofsky, an American specialist in cancer chemotherapy.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
GILOTRIF (afatinib) is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L8...