Brief Title
Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
Official Title
Randomized Phase II Study Of NX 211 Given By Two Different Intravenous Schedules In Advanced And/Or Recurrent Epithelial Ovarian Cancer
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing of die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two treatment regimens of
lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer,
primary fallopian tube cancer, or peritoneal cancer that has been previously treated with
chemotherapy.
Detailed Description
OBJECTIVES: I. Compare the anti-tumor efficacy of two treatment schedules of lurtotecan
liposome, in terms of clinical/radiological response and CA125 tumor marker, in patients with
previously treated advanced or recurrent ovarian epithelial cancer. II. Compare the safety,
pharmacokinetics, and possible pharmacokinetic/pharmacodynamic relationships of these
treatment schedules in these patients. III. Compare the time to progression in patients
treated with these treatment schedules.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to time
from last prior chemotherapy (less than 6 months vs 6 months or more) and number of prior
chemotherapy regimens (1 vs 2). Patients are randomized to one of two treatment arms. Arm I:
Patients receive lurtotecan liposome IV over 30 minutes on days 1-3. Arm II: Patients receive
lurtotecan liposome IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity. Patients achieving complete response
(CR) receive 2 additional courses after documented CR. Patients achieving partial response
(PR) receive 4 additional courses after documented PR or until disease progression at
investigator's discretion. Patients with stable disease continue therapy for a maximum of 6
courses. Patients are followed at 4 weeks and then every 3 months until disease relapse or
progression.
PROJECTED ACCRUAL: A total of 40-74 patients (20-37 per treatment arm) will be accrued for
this study within 10 months.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
lurtotecan liposome
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
81
Start Date
October 31, 2000
Completion Date
September 22, 2008
Primary Completion Date
October 22, 2002
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial cancer Primary
fallopian or peritoneal cancer allowed Clinically and/or radiologically documented advanced
and/or recurrent disease At least one site of disease unidimensionally measurable: Minimum
indicator lesion site as follows: At least 10 mm on spiral CT scan At least 20 mm on
conventional CT scan At least 20 mm on chest x-ray or physical exam No recent prior
radiotherapy to indicator lesion(s) Clear disease progression or new lesion within a
previously irradiated field allowed Previously treated with one or two chemotherapy
regimens At least one regimen must have contained cisplatin or carboplatin (changing from
one prior platinum compound to another for disease progression or failure to respond is
considered a second regimen) Use of same prior chemotherapy combination for first-line and
second-line therapy is considered two regimens No borderline ovarian tumor No ascites as
only disease presentation No abdominal adenocarcinoma of unknown origin No symptomatic
brain metastasis that are potentially life-threatening or require active treatment
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST/ALT
no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No
other prior malignancy within the past 5 years unless definitively treated with no evidence
of recurrence No known hypersensitivity to systemic liposomal formulations or drugs
chemically related to study drug No other serious illness or medical condition that would
preclude study No active uncontrolled infection No complete bowel obstruction No history of
significant neurologic or psychiatric disorder that would preclude informed consent Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or
nitrosourea) and recovered No prior topotecan or other topoisomerase-I inhibitor No other
concurrent cytotoxic therapy for ovarian cancer Endocrine therapy: No concurrent hormonal
therapy for ovarian cancer Radiotherapy: See Disease Characteristics Recovered from prior
radiotherapy At least 4 weeks since prior radiotherapy to area comprising at least 25% of
bone marrow stores Surgery: At least 4 weeks since prior major surgery and recovered Other:
At least 30 days since prior investigational agent or new anticancer therapy No other
concurrent investigational therapy
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Robert N. Grimshaw, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00010179
Organization ID
I138
Secondary IDs
CAN-NCIC-IND138
Responsible Party
Sponsor
Study Sponsor
NCIC Clinical Trials Group
Study Sponsor
Robert N. Grimshaw, MD, Study Chair, Nova Scotia Cancer Centre
Verification Date
April 2020