Clinical trial NCT00753740: Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.
Official title: A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cancer
Ovarian Cancer
Solid Tumor
Keywords: Cancer
Neoplasms
Solid Tumor
Ovarian Cancer
Solid Malignancies
Lead sponsor: Lumos Pharma
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.


Eligibility criteria: Key Inclusion Criteria:

* Women between the age of 18 and 78, inclusive;
* Evidence of platinum-sensitive ovarian cancer following the patient's primary treatment(\>= 6 months);
* Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence of progression;
* May have measurable or unmeasurable disease;
* Eastern Cooperative Oncology Group (ECOG) 0 or 1;
* Ability to understand and the willingness to sign a written informed consent document.

Key Exclusion Criteria:

* Women who are pregnant or lactating;
* Prior treatment with a topoisomerase inhibitor;
* Patients with unacceptable organ and/or hematologic reserve at screening;
* Urine protein of \> 500 mg/day or active nephropathy;
* Electrocardiogram (ECG) with evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator;
* History of pancreatitis within the last 12 months;
* Patients treated with previous high dose chemotherapy or stem cell transplant within the last 5 years;
* Use of any investigational agents within 4 weeks of study enrollment;
* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness or other co-morbidity that presents a risk to the patient as determined by the investigator.

Primary outcomes:
measure: To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week.
timeFrame: 30 weeks
Secondary outcomes:
measure: Comparison of adverse drug experiences between each treatment
timeFrame: 30 weeks
measure: Compare the frequency of drug-related toxicities between each treatment arm
timeFrame: 30 weeks
measure: Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Brightwaters
country: United States
facility: Schwartz Gynecologic Onclology, PLLC
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga GYN Oncology
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Newport News
country: United States
facility: Riverside Gynecology & Oncology
state: Virginia
Study officials:
affiliation: Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center
name: Jonathan S Berek, MD, MMS
role: PRINCIPAL_INVESTIGATOR
affiliation: Anne Murnick Cogan and David H. Cogan Professor of Oncology, Director of the Division of Medical Oncology at NYU Medical Center, and Associate Director for Clinical Research
name: Franco Muggia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schluep T, Hwang J, Cheng J, Heidel JD, Bartlett DW, Hollister B, Davis ME. Preclinical efficacy of the camptothecin-polymer conjugate IT-101 in multiple cancer models. Clin Cancer Res. 2006 Mar 1;12(5):1606-14. doi: 10.1158/1078-0432.CCR-05-1566.
citation: Schluep T, Cheng J, Khin KT, Davis ME. Pharmacokinetics and biodistribution of the camptothecin-polymer conjugate IT-101 in rats and tumor-bearing mice. Cancer Chemother Pharmacol. 2006 May;57(5):654-62. doi: 10.1007/s00280-005-0091-7. Epub 2005 Aug 26.
citation: Cheng J, Khin KT, Davis ME. Antitumor activity of beta-cyclodextrin polymer-camptothecin conjugates. Mol Pharm. 2004 May-Jun;1(3):183-93. doi: 10.1021/mp049966y.