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UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
7-hydroxystaurosporine
topotecan hydrochloride
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring primary peritoneal cavity cancer, recurrent ovarian epithelial cancer, fallopian tube cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer Measurable disease outside of field of prior radiotherapy OR Progressive disease within field after radiotherapy Must have had no more than 2 prior chemotherapy regimens At least 1 prior regimen must have included a platinum agent (e.g., carboplatin or cisplatin) No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 12 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal Creatinine no greater than ULN OR Creatinine clearance at least 50 mL/min Cardiovascular No coronary artery disease No symptomatic cardiac dysfunction No symptoms suggestive of coronary artery disease with evidence of cardiac pathology Pulmonary No symptomatic pulmonary dysfunction Other No prior allergic reaction attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in this study No insulin-dependent diabetes mellitus No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior biologic therapy Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior topotecan (other prior topoisomerase I inhibitors allowed) Endocrine therapy At least 4 weeks since prior hormonal therapy Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to more than 40% of bone marrow No prior mediastinal irradiation Surgery At least 4 weeks since prior surgery Other Recovered from all prior therapy No other concurrent investigational agents No other concurrent anticancer agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UCN-01 in combination with topotecan

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
June 21, 2016
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045175
Brief Title
UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Official Title
A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and topotecan in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Determine the safety and tolerability of this regimen in these patients. Determine the relationship between clinical and pharmacokinetic effects of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of UCN-01 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 additional ovarian epithelial cancer patients are then treated at the recommended phase II dose. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
primary peritoneal cavity cancer, recurrent ovarian epithelial cancer, fallopian tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UCN-01 in combination with topotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
7-hydroxystaurosporine
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer Measurable disease outside of field of prior radiotherapy OR Progressive disease within field after radiotherapy Must have had no more than 2 prior chemotherapy regimens At least 1 prior regimen must have included a platinum agent (e.g., carboplatin or cisplatin) No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 12 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal Creatinine no greater than ULN OR Creatinine clearance at least 50 mL/min Cardiovascular No coronary artery disease No symptomatic cardiac dysfunction No symptoms suggestive of coronary artery disease with evidence of cardiac pathology Pulmonary No symptomatic pulmonary dysfunction Other No prior allergic reaction attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in this study No insulin-dependent diabetes mellitus No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior biologic therapy Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior topotecan (other prior topoisomerase I inhibitors allowed) Endocrine therapy At least 4 weeks since prior hormonal therapy Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to more than 40% of bone marrow No prior mediastinal irradiation Surgery At least 4 weeks since prior surgery Other Recovered from all prior therapy No other concurrent investigational agents No other concurrent anticancer agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hal W. Hirte, MD, FRCP(C)
Organizational Affiliation
Margaret and Charles Juravinski Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

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