This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: September 6, 2002
Last updated: June 21, 2016
Last verified: June 2016

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.

Condition Intervention Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Enrollment: 33
Study Start Date: June 2002
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UCN-01 in combination with topotecan Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN


  • Creatinine no greater than ULN OR
  • Creatinine clearance at least 50 mL/min


  • No coronary artery disease
  • No symptomatic cardiac dysfunction
  • No symptoms suggestive of coronary artery disease with evidence of cardiac pathology


  • No symptomatic pulmonary dysfunction


  • 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


Biologic therapy

  • At least 4 weeks since prior biologic therapy


  • 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


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 40% of bone marrow
  • No prior mediastinal irradiation


  • At least 4 weeks since prior surgery


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00045175

Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
National Cancer Institute (NCI)
Study Chair: Hal W. Hirte, MD, FRCP(C) Margaret and Charles Juravinski Cancer Centre
  More Information

Responsible Party: University Health Network, Toronto Identifier: NCT00045175     History of Changes
Other Study ID Numbers: PMH-PHL-005
CDR0000256917 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: September 6, 2002
Last Updated: June 21, 2016

Keywords provided by University Health Network, Toronto:
primary peritoneal cavity cancer
recurrent ovarian epithelial cancer
fallopian tube cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors processed this record on August 23, 2017