Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00010179

Collaborator

(none)

Enrollment

Locations

94.7

Actual Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: lurtotecan liposome	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 31, 2000

Actual Primary Completion Date :

Oct 22, 2002

Actual Study Completion Date :

Sep 22, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
2	BCCC - Cancer Center for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
3	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
4	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
5	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
6	Queen's University	Kingston	Ontario	Canada	K7L 3N6
7	Royal Victoria Hospital - Montreal	Montreal	Quebec	Canada	H3A 1A1
8	Royal University Hospital	Saskatoon	Saskatchewan	Canada	S7N 0XO
9	City Hospital NHS Trust	Birmingham	England	United Kingdom	B18 7QH
10	Royal Marsden NHS Trust	London	England	United Kingdom	SW3 6JJ
11	Christie Hospital N.H.S. Trust	Manchester	England	United Kingdom	M20 4BX
12	Newcastle General Hospital	Newcastle Upon Tyne	England	United Kingdom	NE4 6BE
13	Weston Park Hospital	Sheffield	England	United Kingdom	S1O 2SJ
14	Beatson Oncology Centre	Glasgow	Scotland	United Kingdom	G11 6NT