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

Information source: University College, London
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: Carboplatin, etoposide & thalidomide (Drug); Carboplatin, etoposide & placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University College, London

Official(s) and/or principal investigator(s):
Siow M. Lee, MD, PhD, FRCP, Study Chair, Affiliation: University College London Hospitals

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.

Clinical Details

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)

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

Primary outcome: Survival at 2 years after study randomization

Secondary outcome:

Time to disease progression 2 years after study randomization

Toxicity as measured by NCIC CTC 3 times weekly while undergoing chemotherapy, then monthly thereafter

Response rates as measured by RECIST during each visit while undergoing chemotherapy and after completion of study treatment

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

Biological markers (measurement of VEGF, bFGF, TNF alpha, and IL-6)

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

University College of London Hospitals, London, England WIT 3AA, United Kingdom
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2003
Last updated: March 15, 2012

Page last updated: August 23, 2015

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