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Docetaxel and Carboplatin With or Without Zoledronate in Treating Patients With Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093717
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy is more effective with or without zoledronate in treating non-small cell lung cancer and preventing bone metastases.

PURPOSE: This randomized phase II trial is studying docetaxel and carboplatin alone to see how well it works compared to giving docetaxel and carboplatin together with zoledronate in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: docetaxel
Drug: zoledronic acid
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Docetaxel Zoledronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Effects of Zometa® in Combination With Taxotere®/Carboplatin in Patients With Stage IIIB/IV Unresectable Non-Small Cell Lung Cancer

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

Primary Outcome Measures:
  • Proportion of patients with no disease progression after 6 courses [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Time to progression in bone [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: August 2004
Detailed Description:

OBJECTIVES:

Primary

  • Compare the proportion of patients without disease progression at 6 months among patients with unresectable stage IIIB or stage IV non-small cell lung cancer treated with docetaxel and carboplatin with vs without zoledronate.

Secondary

  • Compare time to disease progression in patients treated with these regimens.
  • Compare response rate in patients treated with these regimens.
  • Compare time to progression in bone in patients treated with these regimens.
  • Compare 1-year overall survival in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour followed by zoledronate IV over 15 minutes and carboplatin IV over 15 minutes on day 1.
  • Arm II: Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 15 minutes on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of therapy, patients in arm I who have responding or stable disease are then re-randomized to 1 of 2 arms.

  • Arm I: Patients receive zoledronate IV over 15 minutes monthly for 12 months from the date of the first chemotherapy dose.
  • Arm II: Patients receive no further treatment. Patients are followed every 1 or 3 months for 12 months from the date of the first chemotherapy dose.

PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenocarcinoma, and large cell carcinoma

    • Unresectable stage IIIB disease, including patients with pleural effusion

      • Patients with stage IIIB who are candidates for combined chemotherapy and chest irradiation are not eligible
    • Stage IV disease
    • No mixed tumors with small cell carcinoma or aplastic carcinoma
  • Measurable disease

    • At least one measurable lesion outside a previously irradiated area and detectable by radiologic studies
  • No bone metastases
  • No brain metastases unless treated and stable for at least 8 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 3 months

Hematopoietic

  • WBC ≥ 1,500/mm^3
  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • Bilirubin ≤ upper limit of normal (ULN)
  • Alkaline phosphatase and AST/ALT must meet criteria for one of the following:

    • AST or ALT ≤ 5 times ULN AND alkaline phosphatase ≤ ULN
    • AST or ALT ≤1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
    • AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN
  • No hepatic disease that would preclude prolonged follow-up

Renal

  • Creatinine clearance > 60 mL/min
  • Calcium ≥ 8.0 mg/dL (corrected)
  • No renal disease that would preclude prolonged follow-up

Cardiovascular

  • No cardiovascular disease that would preclude prolonged follow-up

Pulmonary

  • No pulmonary disease that would preclude prolonged follow-up

Other

  • No weight loss > 5% within the past 6 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except treated melanoma, ductal carcinoma in situ of the cervix, or other cancer cured by resection alone
  • No known hypersensitivity to zoledronate, other bisphosphonates, platinum-containing compounds, mannitol, or polysorbate 80
  • No peripheral neuropathy > grade 1
  • No uncontrolled infections
  • No uncontrolled type 2 diabetes mellitus
  • No disease with influence on bone metabolism, including any of the following:

    • Paget's disease
    • Uncontrolled thyroid dysfunction
    • Uncontrolled parathyroid dysfunction
  • No neurologic/psychiatric disease that would preclude prolonged follow-up
  • No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior first-line chemotherapy

    • Prior adjuvant or neoadjuvant treatment (including paclitaxel) for NSCLC is allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy covering > 30% of marrow-bearing areas
  • No concurrent radiotherapy

Surgery

  • More than 3 weeks since prior thoracotomy and recovered

Other

  • More than 30 days since prior systemic investigational drugs or devices
  • More than 1 year since prior bisphosphonates
  • No other concurrent bisphosphonates
  • No other concurrent osteoclastic bone resorption inhibitors (e.g., calcitonin, mithramycin, or gallium nitrate)
  • No other concurrent investigational drugs or devices
  • No other concurrent antineoplastic agents during the treatment phase of study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093717

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Robert A. Figlin, MD, FACP 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: CDR0000389497, UCLA-0405098-01, NOVARTIS-CZO4L44EUS75
Study First Received: October 6, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00093717  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung
large cell lung cancer
squamous 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
Zoledronic acid
Carboplatin
Carcinoma
Docetaxel
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009