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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.
First Received: September 6, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045175
  Purpose

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
Peritoneal Cavity Cancer
Drug: 7-hydroxystaurosporine
Drug: topotecan hydrochloride
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: UCN 01 Topotecan hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045175

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000256917, PMH-PHL-005, NCI-5518
Study First Received: September 6, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00045175     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
peritoneal cavity cancer
recurrent ovarian epithelial cancer
fallopian tube cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Protein Kinase Inhibitors
Genital Diseases, Female
Peritoneal Diseases
Staurosporine
Ovarian Cancer
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
7-hydroxystaurosporine
Abdominal Neoplasms
Ovarian Epithelial Cancer
Recurrence
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy
Topotecan

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Protein Kinase Inhibitors
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Staurosporine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
7-hydroxystaurosporine
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Peritoneal Neoplasms
Topotecan

ClinicalTrials.gov processed this record on May 07, 2009