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

Sponsor:	Princess Margaret Hospital, Canada
Collaborator:	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 Primary Peritoneal Cavity Cancer	Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride	Phase I

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: UCN 01 Topotecan hydrochloride Topotecan

U.S. FDA Resources

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
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

Princess Margaret Hospital, Canada

National Cancer Institute (NCI)

Investigators

Study Chair:

Hal W. Hirte, MD, FRCP(C)

Margaret and Charles Juravinski Cancer Centre

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00045175 History of Changes
Other Study ID Numbers:	CDR0000256917, PMH-PHL-005, NCI-5518
Study First Received:	September 6, 2002
Last Updated:	April 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

primary peritoneal cavity cancer
recurrent ovarian epithelial cancer
fallopian tube cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms

Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
7-hydroxystaurosporine
Topotecan
Staurosporine
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Topoisomerase I Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012