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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients with no disease progression after 6 courses
Safety Issue:
No
Principal Investigator
Robert A. Figlin, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000389497
NCT ID:
NCT00093717
Start Date:
August 2004
Completion Date:
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
