Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

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 UCLALos Angeles, California  90095-1781