A Phase I/II Study to Determine the MTD and Safety of CC-4047 Administered in Conjunction With Cisplatin and Etoposide - Full Text View

A Phase I/II Study to Determine the MTD and Safety of CC-4047 Administered in Conjunction With Cisplatin and Etoposide

This study is currently recruiting participants.
Verified by Celgene Corporation, August 2008

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00537511

Purpose

The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer

Condition	Intervention	Phase
Carcinoma, Small Cell	Drug: CC-4047	Phase I Phase II

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Etoposide Cisplatin Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Phase I/IIA, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose and To Evaluate the Safety Profile of CC-4047 Administered in Combination With Cisplatin and Etoposide in Patients With Extensive Disease Small Cell Lung Cancer

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Appearance of dose-limiting toxicities [ Time Frame: During Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety of CC-4047 in combination with cisplatin and etoposide [ Time Frame: Cycles 2-6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	December 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental CC-4047 + cisplatin + etoposide	Drug: CC-4047 Dose finding arm: CC-4047 (0.5-5.0mg QD days 1-14 of each 21 day cycle) + cisplatin + etoposide

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

signature of informed consent
Age >= 18
histologically or cytologically confirmed SCLC
extensive stage SCLC
ECOG 0, 1 or 2
brain metastases that are asymptomatic and do not require steroid control
females of child bearing potential must use two forms of birth control

Exclusion Criteria:

pregnant or lactating females
prior use of cytotoxic chemotherapy
surgery within 14 days of study
radiation within 14 days of study
prior therapy with CC-4047, lenalidomide or thalidomide
concurrent use or anticipated use of anti-cancer agents
ANC < 1500/mm^3
platelets < 100 x 10^3/uL
serum creatinine >2.5 mg/dL
serum SGOT or SGPT > 3.0 x ULN
serum total bilirubin > 1.8 mg/dL
uncontrolled hypercalcemia
creatinine clearance <50 mL/min
uncontrolled hypertension
neuropathy >= grade 2
BMI >= 40
any other active invasive malignancy requiring treatment
known chronic infection with HIV, HBV or HCV
inability or unwillingness to comply with birth control requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537511

Contacts


Contact: Brian A Tozzi, MS	+1 908 673 9000	btozzi@celgene.com

Locations


United States, Ohio
		Recruiting
	Cleveland, Ohio, United States, 44106

United States, Pennsylvania
		Not yet recruiting
	Hershey, Pennsylvania, United States, 17033

United States, Texas
		Recruiting
	Dallas, Texas, United States, 75390

Canada, Ontario
		Recruiting
	Hamilton, Ontario, Canada, L8V 5C2
		Recruiting
	Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec
		Not yet recruiting
	Montreal, Quebec, Canada, H2W 1S6

Sponsors and Collaborators

Celgene Corporation

Investigators


Study Director:	Ulf Jungnelius, MD	Celgene Corporation

More Information

Responsible Party:	Celgene Corporation ( Jarl Ulf Jungnelius )
Study ID Numbers:	CC-4047-SCLC-002
First Received:	September 27, 2007
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00537511
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Thoracic Neoplasms

Carcinoma, Neuroendocrine

Etoposide phosphate

Carcinoma

Neuroendocrine Tumors

Carcinoma, Small Cell

Neuroectodermal Tumors

Cisplatin

Respiratory Tract Diseases

Lung Neoplasms

Neoplasms, Germ Cell and Embryonal

Lung Diseases

Neuroepithelioma

Adenocarcinoma

Etoposide

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Radiation-Sensitizing Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Neoplasms, Nerve Tissue

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008