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Randomized Phase II Study Of NX 211 Given By Two Different Intravenous Schedules In Advanced And/Or Recurrent Epithelial Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

Randomized Phase II Study Of NX 211 Given By Two Different Intravenous Schedules In Advanced And/Or Recurrent Epithelial Ovarian Cancer

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

PROJECTED ACCRUAL: A total of 40-74 patients (20-37 per treatment arm) will be accrued for
this study within 10 months.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert N. Grimshaw, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Nova Scotia Cancer Centre


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

September 2008

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial