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ZD6474, Carboplatin, and Paclitaxel in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2007
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093392
  Purpose

RATIONALE: ZD6474 may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining ZD6474 with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with ZD6474 works compared to carboplatin and paclitaxel alone in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: placebo
Drug: vandetanib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel Vandetanib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control
Official Title: A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 Alone or in Combinaiton With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response rate [ Designated as safety issue: No ]
  • Disease control rate [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: May 2004
Arms Assigned Interventions
Arm I (part 2 randomized phase): Experimental
Patients receive oral ZD6474 once daily at the appropriate and tolerable dose determined in part 1.
Drug: vandetanib
Given orally
Arm II (part 2 randomized phase): Experimental
Patients receive oral ZD6474 once daily on days 1-21 and paclitaxel and carboplatin as in part 1. Treatment repeats every 21 days for 6 courses. Patients achieving a PR, CR, or SD after 6 courses of therapy receive oral ZD6474 alone once daily.
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: vandetanib
Given orally
Arm III (part 2 randomized phase): Active Comparator
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in part 1. Treatment repeats every 21 days for 6 courses. Patients achieving a PR, CR, or SD after 6 courses of therapy receive oral placebo alone once daily.
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: placebo
Given orally

  Show Detailed Description

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:

    • Stage IIIB with pleural effusion
    • Stage IV
    • Previously resected stage I-III disease that has relapsed in the non-resected metastatic site
  • Measurable disease

    • At least 1 lesion ≥ 10 mm by spiral CT scan OR ≥ 20 mm by conventional techniques
  • Considered suitable for first-line treatment with paclitaxel, carboplatin, and ZD6474
  • No mixed small cell and non-small cell histology
  • No brain metastasis or spinal cord compression unless both of the following are true:

    • Treated at least 4 weeks ago
    • Stable without steroids for 1 week

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-1

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN (5.0 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine clearance ≥ 30 mL/min
  • Calcium (ionized or adjusted for albumin) normal* NOTE: *Supplementation allowed

Cardiovascular

  • LVEF ≥ 45% by MUGA or echocardiogram*
  • No significant cardiac event, including symptomatic heart failure or symptomatic angina within the past 3 months
  • No congenital long QT syndrome
  • No QT with Bazett's correction unmeasurable or ≥ 460 msec by ECG
  • No superior vena cava syndrome
  • No cardiac disease that would increase the risk of ventricular arrhythmia
  • No uncontrolled hypertension (i.e., systolic blood pressure (BP) > 160 mm Hg OR diastolic BP > 100 mm Hg)
  • No history of QT interval prolongation while taking other medication unless approved by the investigator
  • No history of chronic atrial fibrillation
  • No clinically significant symptomatic arrhythmia (e.g., multifocal pre-ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia) requiring treatment
  • No symptomatic sustained ventricular tachycardia NOTE: *For patients with prior anthracycline therapy (total dose > 450 mg/m2), significant cardiovascular disease, or chest irradiation

Pulmonary

  • No clinically significant hemoptysis within the past 3 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Potassium ≥ 3.5 mEq/L*
  • Magnesium normal*
  • No active skin disease (e.g., acne, psoriasis, or eczema)
  • No active gastrointestinal disease that would preclude absorption of ZD6474 or tolerating diarrhea
  • No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
  • No other condition that would preclude study participation or compliance NOTE: *Supplementation allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy
  • No concurrent biologic response modifiers, including cytokines

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormonal therapy

Radiotherapy

  • No prior radiotherapy

    • Prior radiotherapy to the brain or palliative radiotherapy for bone metastasis allowed
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No prior adjuvant or neoadjuvant therapy
  • More than 30 days since prior participation in an investigational trial
  • More than 2 weeks since prior and no concurrent administration of the following:

    • Potent inhibitors of CYP3A4, including any of the following:

      • Ketoconazole
      • Itraconazole
      • Felbamate
      • Fluoxetine
      • Fluvoxamine
      • Lansoprazole
      • Amiodarone
      • Azithromycin
      • Ciprofloxacin
      • Clarithromycin
      • Cimetidine
      • Diltiazem
      • Erythromycin
      • Fluconazole
      • Nefazodone
      • Dolasetron
      • Ritonavir
      • Verapamil
      • Grapefruit juice
      • Seville oranges
    • Potent inducers of CYP3A4, including any of the following:

      • Rifampin
      • Phenytoin
      • Carbamazepine
      • Barbiturates
      • Hypericum perforatum (St. John's wort)
    • Therapeutic doses of warfarin for an INR ≥ 2

      • Concurrent low-dose warfarin for catheter clot prophylaxis allowed
    • Medications that prolong QTc interval or induce Torsades de Pointes
    • Medications that cause sustained elevations in gastric pH (pH ≥ 5)
  • No blood donation during and for 3 months after study participation
  • No other concurrent cytotoxic agents
  • No other concurrent cancer therapy or investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093392

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-7187
Contact: Fairooz F. Kabbinavar, MD     310-206-3921        
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Fairooz F. Kabbinavar, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000386240, UCLA-0405022-01, ZENECA-D4200C00007, ZENECA-D4200C007A
Study First Received: October 6, 2004
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00093392  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

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

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009