NCT00045175

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

11 years

First QC Date

September 6, 2002

Last Update Submit

June 21, 2016

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

primary peritoneal cavity cancerrecurrent ovarian epithelial cancerfallopian tube cancer

Study Arms (1)

UCN-01 in combination with topotecan

EXPERIMENTAL
Drug: 7-hydroxystaurosporineDrug: topotecan hydrochloride

Interventions

7-hydroxystaurosporineDRUG
UCN-01 in combination with topotecan
topotecan hydrochlorideDRUG
UCN-01 in combination with topotecan

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

7-hydroxystaurosporineTopotecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Hal W. Hirte, MD, FRCP(C)

    Margaret and Charles Juravinski Cancer Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

June 1, 2002

Primary Completion

June 1, 2013

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

CA(3)