Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Approved-not yet active 18 and over Pharmaceutical / Industry INNO-206-P2 NCT00472771

Trial Description

Summary

The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.

Further Study Information

This is a phase II, open-label, prospective, multicenter, single-arm study of INNO 206 in adult patients with recurrent extensive small cell lung cancer sensitive to first-line platinum-based therapy. The primary objective of the study is to determine the objective overall response rate. Secondary objectives include evaluating the treatment-related toxicities in this patient population and determining the pharmacokinetic (PK) profile of INNO-206 in a minimum of 12 patients.

Eligibility Criteria

Inclusion Criteria:

• Be ≥18 years old.

• Have a histologically or cytologically confirmed diagnosis of recurrent extensive small cell lung cancer (SCLC) at the time of enrollment into the study.

• Have responded to first-line platinum-based chemotherapy, but progressed or relapsed ≥60 days after completion of first-line therapy.

• Have measurable disease defined by RECIST.

• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.

• Have an estimated life expectancy of ≥4 weeks.

• Be male or non-pregnant, non-lactating female patients. Patients who are fertile must agree to use an effective barrier method of birth control to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication.

• Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study medication (if patient is a female of childbearing potential).

• Have adequate organ function.

Exclusion Criteria:

• Are pregnant or lactating.

• Have received prior anthracycline therapy.

• Have participated in any investigational drug study within 30 days prior to study entry.

• Have received radiotherapy within 2 weeks of treatment in this study.

• Have not recovered from acute toxicity of all previous therapy prior to enrollment.

• Have a history of a malignancy other than SCLC. Exceptions to this include: curatively treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix, or prior low-grade, localized prostate cancer (Gleason score ≤6); or a history of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.

• Have symptomatic central nervous system (CNS) metastases.

• Have any concurrent severe or uncontrolled medical disease (such as active systemic infection, hypertension, congestive heart failure ≥NYHA Grade II, myocardial infarction within 6 months before study start, severe rhythm disturbances, etc.) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.

• Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.

• Have received radiotherapy with >25% involvement of the bone marrow within 6 weeks prior to study start.

• Have a known hypersensitivity to doxorubicin, 5% D-(+)-sucrose, 10 mM sodium phosphate, and/or 0.3% N-acetyltryptophane.

Trial Contact Information

Trial Lead Organizations/Sponsors

Innovive Pharmaceuticals

Michael Maitland, MD

Principal Investigator

Dan Smoker		Ph: 513-579-9911
		Email: d.smoker@medpace.com

U.S.A.
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Livia Szeto, RN	Ph: 773-834-0783
			Email: lszeto@medicine.bsd.uchicago.edu
		Michael Maitland, MD, PhD	Principal Investigator
Montana
	Billings
	Billings Clinic Cancer Center
		Kathy Wilkinson	Ph: 406-238-2866
			Email: kwilkinson@billingsclinic.org
		James Burke, MD	Principal Investigator
New York
	Albany
	New York Oncology Hematology, PC - Albany
		Michele Butler	Ph: 518-489-2607
			Email: michele.butler@usoncology.com
		James C. Arseneau	Principal Investigator
Ohio
	Kettering
	Dayton Oncology and Hematology, PA - Kettering
		Michelle Owens	Ph: 937-528-0317
			Email: michelle.owens@usoncology.com
		Robert N. Raju	Principal Investigator
	Middletown
	Signal Point Hematology Oncology Incorporated
		Susan Smith, RN	Ph: 513-423-0504
			Email: susan_smith@swohio.twcbc.com
		Nandagopal Vrindavanam, MD	Principal Investigator
South Carolina
	Greenville
	Cancer Centers of the Carolinas - Eastside
		Julie Martin	Ph: 864-679-3966
			Email: julie.martin@usoncology.com
		Joe J. Stephenson	Principal Investigator
Texas
	Dallas
	Mary Crowley Medical Research Center at Sammons Cancer Center
		JR Doan, RN	Ph: 214-658-1943
			Email: jdoan@mcmrc.com
		Neil Senzer, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00472771
Information obtained from ClinicalTrials.gov on May 27, 2008