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A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- Compare the overall survival of patients with stage IIIB or IV non-small cell lung
cancer treated with gemcitabine and carboplatin followed by immediate vs delayed
docetaxel.

Secondary

- Compare the response rate and time to progression in patients treated with these
regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance
status (0 or 1 vs 2).

All patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and carboplatin IV
over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

Patients with stable or responding disease proceed to docetaxel therapy. Patients are
randomized to 1 of 2 treatment arms.

- Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day
1.

- Arm II (delayed docetaxel): Patients are observed until first evidence of disease
progression and then receive docetaxel IV over 1 hour on day 1.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life (QOL) is assessed at baseline, at restaging (after completion of gemcitabine
and carboplatin), before courses 2-6 of docetaxel*, and then at 1 and 3 months after study
treatment.

NOTE: *For patients randomized to delayed docetaxel, QOL is assessed every 3 weeks until
first disease progression and then before courses 2-6 of docetaxel

Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3
months thereafter.

PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage IIIB with pleural effusion OR stage IV disease

- Recurrent disease after primary treatment with radiotherapy or surgery allowed

- Measurable disease or nonmeasurable disease

- Measurable disease, defined as at least 1 unidimensionally measurable lesion at
least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Nonmeasurable disease, defined as all other lesions, including small lesions
(longest diameter less than 20 mm by conventional techniques OR less than 10 mm
by spiral CT scan) or any of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Cystic lesions

- Abdominal masses not confirmed and followed by imaging techniques

- No symptomatic CNS metastases

- Treated, stable CNS metastases allowed provided patient is not receiving
radiotherapy or corticosteroids

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN
for patients with documented benign disease)

- Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign
disease)

Renal

- Creatinine no greater than 1.5 mg/dL

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 3 months after study
participation

- No active and ongoing infection

- No concurrent serious systemic disorder that would preclude study participation

- No other primary malignancy within the past 5 years except carcinoma in situ of the
cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in
remission

- Other prior cancers unlikely to affect survival for the next 3 years (e.g.,
low-grade early stage prostate cancer) are allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

Chemotherapy

- No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy

- No other concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- No concurrent antitumor hormonal therapy (excluding contraceptives and replacement
steroids)

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated
area is not the only site of measurable disease

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

Other

- At least 3 weeks since prior therapy for cancer

- More than 4 weeks since prior investigational agents

- No other concurrent experimental medications

- No other concurrent therapy for cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter

Safety Issue:

No

Principal Investigator

Nathan Levitan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LILY1503

NCT ID:

NCT00074204

Start Date:

October 2003

Completion Date:

April 2008

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065