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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
PrECOG, LLC.
ClinicalTrials.gov Identifier:
NCT00687297
First received: May 27, 2008
Last updated: November 28, 2012
Last verified: November 2012
  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 induction
Drug: Docetaxel
Drug: Carboplatin
Drug: Placebo
Drug: Vandetanib maintenance
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by PrECOG, LLC.:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance)) ] [ Designated as safety issue: No ]
    Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation.


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance)) ] [ Designated as safety issue: No ]
    Best overall response (complete or partial response), assessed using RECIST criteria (version 1.0)

  • Progression-free Survival [ Time Frame: every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance) ] [ Designated as safety issue: No ]
    Time from randomization to first evidence of disease progression or death. Patients alive without progression are censored at the date of last disease evaluation.


Enrollment: 162
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vandetanib Maintenance
Docetaxel day 1, carboplatin day 1 + vandetanib induction days 1 through 21 (daily) of a 28-day cycle for 4 cycles. If free of disease progression after 4 cycles, vandetanib maintenance daily until progression.
Drug: vandetanib induction
100 mg daily by mouth
Other Name: ZD6474
Drug: Docetaxel
(75mg/m2) IV (in the vein) on day 1 of a 21-day cycle for 4 cycles or until disease progression
Other Name: Taxotere
Drug: Carboplatin
IV (in the vein) to area under the curve (AUC) of 6 on day 1 of a 21 day cycle, for 4 cycles or until disease progression
Drug: Vandetanib maintenance
300 mg daily by mouth
Other Name: ZD6474
Placebo Comparator: Placebo Maintenance
Docetaxel day 1, carboplatin day 1 + vandetanib induction days 1 through 21 (daily) of a 28-day cycle for 4 cycles. If free of disease progression after 4 cycles, placebo maintenance daily until progression.
Drug: vandetanib induction
100 mg daily by mouth
Other Name: ZD6474
Drug: Docetaxel
(75mg/m2) IV (in the vein) on day 1 of a 21-day cycle for 4 cycles or until disease progression
Other Name: Taxotere
Drug: Carboplatin
IV (in the vein) to area under the curve (AUC) of 6 on day 1 of a 21 day cycle, for 4 cycles or until disease progression
Drug: Placebo

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  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) ≥ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 30 Study Locations
Sponsors and Collaborators
PrECOG, LLC.
AstraZeneca
Investigators
Study Chair: Joseph Aisner, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: PrECOG, LLC.
ClinicalTrials.gov Identifier: NCT00687297     History of Changes
Other Study ID Numbers: PrE0501, IRUSZACT0088
Study First Received: May 27, 2008
Results First Received: June 6, 2012
Last Updated: November 28, 2012
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014