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

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Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by PrECOG, LLC., February 2009
Sponsors and Collaborators: PrECOG, LLC.
AstraZeneca

Information provided by: PrECOG, LLC.
ClinicalTrials.gov Identifier: NCT00687297

Purpose
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



Condition Intervention Phase
Lung Cancer
Non Small Cell Lung Cancer
Drug: vandetanib
Phase II




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Docetaxel Vandetanib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination With Docetaxel and Carboplatin Followed by Placebo or Maintenance Therapy With Vandetanib in Patients With IIIb, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)


Further study details as provided by PrECOG, LLC.:


Primary Outcome Measures:
To determine the progression-free survival after treatment with the combination of docetaxel, carboplatin in patients with IIIb or IV non-small cell lung cancer. [ Time Frame: first evidence of disease progression ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
To evaluate the safety and tolerability of the two regimens [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

To determine the objective response rate in each arm [ Time Frame: Three months ] [ Designated as safety issue: No ]

If both arms demonstrate benefit over historical control, to explore whether vandetanib as maintenance therapy confers added PFS benefit [ Time Frame: Twelve months ] [ Designated as safety issue: No ]


Estimated Enrollment: 160
Study Start Date: April 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator
Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days] Drug: vandetanib
100 mg tablets, 100 mg daily with chemotherapy (Both arms A & B receive active drug for first 4 cycles). 300 mg daily (or 3 matching placebo tablets) alone as maintenance treatment
B: Placebo Comparator
Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days] Drug: vandetanib
100 mg tablets, 100 mg daily with chemotherapy (Both arms A & B receive active drug for first 4 cycles). 300 mg daily (or 3 matching placebo tablets) alone as maintenance treatment


Show Detailed Description


Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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) ¡Ã 1500/mm©ø and platelet count ¡Ã 100,000/mm©ø
Hemoglobin ¡Ã 9 gm/dL
Total bilirubin ¡Â 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 ¡Â 2 X institutional ULN.
AST, ALT and alkaline phosphatase (Alk Phos) must be ¡Â 1.5 ULN
Creatinine ¡Â 1.5 X institutional ULN or calculated creatinine clearance ¡Ã 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 ¡Ã 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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687297

Show 28 Study Locations

Sponsors and Collaborators
PrECOG, LLC.
AstraZeneca
Investigators
Study Chair: Joseph Aisner, MD Cancer Institute of New Jersey

More Information

Responsible Party: PrECOG, LLC ( Peter O'Dwyer, MD/Chief Executive Officer )
Study ID Numbers: PrE0501, IRUSZACT0088
Study First Received: May 27, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00687297 [history]
Health Authority: United States: Food and Drug Administration

Keywords provided by PrECOG, LLC.:
Stage IIIB Non Small Cell Lung Cancer
Stage IV Non Small Cell Lung Cancer
Vandetanib
Docetaxel plus carboplatin



Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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