Carboplatin and Etoposide With or Without Thalidomide in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061919
• Other study ID #: CDR0000302440
• Secondary ID: LLCG-STUDY-12EU-
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2003
• Last updated: March 15, 2012
• Start date: April 2003
• Est. completion date: July 2007

Study information

• Verified date: March 2012
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating small cell lung cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer.

Description:

OBJECTIVES:

• 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 study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: July 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer

• Limited or extensive stage disease

• No symptomatic brain metastases requiring immediate radiotherapy

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-3

Life expectancy

• At least 8 weeks

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

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

• Creatinine clearance greater than 50 mL/min

Other

• 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 participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy

Surgery

• Not specified

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Carboplatin, etoposide & thalidomide
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.
• Carboplatin, etoposide & placebo
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.

Locations

Country	Name	City	State
United Kingdom	University College of London Hospitals	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Lee SM, Woll PJ, Rudd R, Ferry D, O'Brien M, Middleton G, Spiro S, James L, Ali K, Jitlal M, Hackshaw A. Anti-angiogenic therapy using thalidomide combined with chemotherapy in small cell lung cancer: a randomized, double-blind, placebo-controlled trial. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 2 years after study randomization		0-2 years	No
Secondary	Time to disease progression 2 years after study randomization		0-2 years	No
Secondary	Toxicity as measured by NCIC CTC 3 times weekly while undergoing chemotherapy, then monthly thereafter		Till end of treatment	Yes
Secondary	Response rates as measured by RECIST during each visit while undergoing chemotherapy and after completion of study treatment		Till progression	No
Secondary	Quality of life as measured by EORTC QLQ-30 and lung-specific questionnaire(LC14) at baseline, after each course, and after completion of study treatment, and at 6, 12, 18, and 24 months after day 1 of course 1		0-24 months	No
Secondary	Biological markers (measurement of VEGF, bFGF, TNF alpha, and IL-6)		Before treatment courses 1 and 4, and then at 9 and 18 months	No