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A Phase II Trial of Concurrent Carboplatin/VP-16 and Radiation Followed by Paclitaxel (Taxol) for Poor-Risk Stage III Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Concurrent Carboplatin/VP-16 and Radiation Followed by Paclitaxel (Taxol) for Poor-Risk Stage III Non-Small Cell Lung Cancer

OBJECTIVES: I. Assess the survival and failure-free survival in poor risk patients with
stage IIIA or IIIB non-small cell lung carcinoma treated with concurrent radiation,
carboplatin, and etoposide followed by consolidation with paclitaxel. II. Evaluate the
response and toxicities associated with this regimen in this group of poor risk patients.

OUTLINE: This is nonrandomized study. Chemotherapy on cycle 1 starts on day 1 with
concurrent initiation of radiotherapy. Chemotherapy is given prior to radiotherapy on those
days when both treatments are given. Cycle 2 begins on day 29. Carboplatin is administered
by 15 minute IV infusions on days 1, 3, 29, and 31. Etoposide (VP-16) is administered after
carboplatin by 30 minute IV infusions on days 1-4, and 29-32. Radiation therapy begins
within 24 hours of day 1, cycle 1 of chemotherapy. The primary tumor, the adjacent
mediastinum, and other targeted lymph nodes are administered radiotherapy daily 5 days a
week for 6.5 weeks. After the 2 cycles of chemotherapy and chest radiotherapy, patients who
have stable disease, partial response, or complete response receive 3 cycles of paclitaxel.
Paclitaxel is administered by 3 hour IV infusions starting 4 weeks after completion of
chemotherapy and radiotherapy and repeated every 3-4 weeks (approximately days 71, 92, and
103) for a total of 3 cycles. Patients are followed every month for the first year, every 3
months for the second year, every 6 months for the third year, and then annually thereafter
while on treatment. After treatment, patients are followed every 6 months for 2 years and
then annually thereafter.

PROJECTED ACCRUAL: There will be 80 patients accrued in this study over 16 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed single primary
bronchogenic non-small cell lung cancer (NSCLC) Stage IIIA (T1-2 N2 M0; T3 N0-2 M0) or
IIIB (T4 or N3 M0, excluding malignant pleural effusion) Following NSCLC cellular types
are eligible: adenocarcinoma large cell carcinoma squamous cell carcinoma unspecified
Histology or cytology from involved mediastinal or supraclavicular nodes are sufficient
for diagnosis if a separate primary lesion of the lung parenchyma is clearly evident on
radiographs Radiographic evidence of mediastinal lymph nodes of at least 1.5 cm in the
largest diameter is sufficient to stage N2 or N3 If the largest mediastinal nodes are less
than 1.5 cm in diameter and this is the basis for stage III disease, then at least one of
the nodes has to be proven positive cytologically or histologically No bronchioloalveolar
carcinoma or stage IIIB tumor involving the superior sulcus Patients must meet at least
one of the following conditions: - FEV1 less than 2 liters and predicted FEV1 of the
contralateral lung no greater than 800 mL based on the quantitative split function testing
- Creatinine clearance less than 50 mL/min - Significant clinical hearing loss and
unwilling to accept the potential for worsening due to cisplatin - Controlled congestive
heart failure that, in the opinion of the investigator, may become decompensated due to
excessive hydration prior to cisplatin administration - SWOG performance status 2 and
either albumin less than 0.85 times upper limit of normal or weight loss of greater than
10% due to tumor Measurable or evaluable disease Patients with pleural effusion are
eligible only if: - pleural fluid must be a transudate with negative cytology if present
before mediastinoscopy or exploratory thoracotomy - pleural fluid can be either transudate
or exudate with negative cytology if present only after exploratory or staging thoracotomy
but not before - in any case, pleural effusion is present only on CT scan but not on
decubitus chest x-ray, and it is deemed too small to tap under either CT or ultrasound

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
upper limit of normal SGOT no greater than 1.5 times upper limit of normal Renal:
Creatinine clearance at least 20 mL/min Cardiovascular: No unstable congestive heart
failure No active angina No unstable cardiac arrhythmias Pulmonary: FEV1 at least 1.0
liter Also See Disease Characteristics Other: No uncontrolled peptic ulcer disease No
active infection No prior malignancy except adequately treated basal cell or squamous cell
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease free for 5 years Not pregnant or nursing Adequate contraception required of all
fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation for lung
cancer Surgery: No prior surgery for lung cancer

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Derick H. Lau, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

December 2007

Related Keywords:

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



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