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A Phase III Randomized, Double Blind, Placebo Controlled Trial Of Carboplatin/Etoposide With Or Without Thalidomide In Small Cell Lung Cancer (Study 12)

Phase 3
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Phase III Randomized, Double Blind, Placebo Controlled Trial Of Carboplatin/Etoposide With Or Without Thalidomide In Small Cell Lung Cancer (Study 12)


- Compare the survival of patients with limited or extensive stage small cell lung cancer
treated with carboplatin and etoposide with vs without thalidomide.

- Compare the time to disease progression in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the response rates of patients treated with these regimens.

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

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to disease stage (limited vs extensive), ECOG performance status (0
and 1 vs 2), and alkaline phosphatase (no greater than 1.5 times upper limit of normal [ULN]
vs greater than 1.5 times ULN). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive carboplatin IV over 30 minutes on day 1 and etoposide* IV over
1-2 hours on days 1 and 2 and orally on day 3. Patients also receive oral thalidomide
daily beginning on day 1.

- Arm II: Patients receive carboplatin and etoposide as in arm I and oral placebo daily
beginning on day 1.

NOTE: *Patients who are unable to receive etoposide IV on day 2 may receive oral etoposide
on days 2 and 3.

In both arms, chemotherapy (carboplatin and etoposide) repeats every 3 weeks for up to 6
courses. Patients receive thalidomide or placebo continuously for up to 2 years. Treatment
continues in the absence of disease progression or unacceptable toxicity. Patients who
experience disease progression may continue to receive thalidomide or placebo provided the
patient is clinically and symptomatically stable.

Quality of life is assessed at baseline, during each course of chemotherapy, at 3-4 weeks
after completion of chemotherapy, and at 6, 12, 18, and 24 months.

Patients are followed every 2 months for 2 years after the completion of chemotherapy and
then every 3 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 372 patients (186 per treatment arm) will be accrued for this

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer

- Limited or extensive stage disease

- No symptomatic brain metastases requiring immediate radiotherapy



- Over 18

Performance status

- ECOG 0-3

Life expectancy

- At least 8 weeks


- Not specified


- Not specified


- Ethylenediamine tetraacetic acid (EDTA) clearance greater than 60 mL/min OR

- Creatinine clearance greater than 50 mL/min


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception (including 1 highly
effective method and 1 barrier method) during and for 4 weeks after study completion

- No other prior malignancy within the past 3 years except nonmelanoma skin cancer or
early cervical cancer

- No significant medical condition or laboratory finding that would preclude study


Biologic therapy

- Not specified


- No prior chemotherapy

Endocrine therapy

- Not specified


- See Disease Characteristics

- No prior radiotherapy


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Survival at 2 years after study randomization

Outcome Time Frame:

0-2 years

Safety Issue:


Principal Investigator

Siow M. Lee, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

April 2003

Completion Date:

July 2007

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma