Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

February 5, 2003

Last Updated Date

August 6, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00054119 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Official Title ^ICMJE

A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment.

Detailed Description

OBJECTIVES:

Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.
Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter .

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Ovarian Cancer
Peritoneal Cavity Cancer

Intervention ^ICMJE

Drug: karenitecin

Study Arms / Comparison Groups

Publications *

Kavanagh JJ, Sill MW, Ramirez PT, Warshal D, Pearl ML, Morgan MA. Phase II multicenter open-label study of karenitecin in previously treated epithelial ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Int J Gynecol Cancer. 2007 Sep 13; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed ovarian epithelial or primary peritoneal cancer
- Recurrent or persistent disease
- Platinum-resistant disease
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target)
Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

GOG 0-2

Life expectancy

Not specified

Hematopoietic

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

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
ALT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

No myocardial infarction within the past 6 months
No cerebrovascular accident within the past 6 months
No transient ischemic attack within the past 6 months
No uncontrolled hypertension
No decompensated or uncontrolled chronic heart failure

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No neuropathy (sensory or motor) grade 2 or greater
No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
No active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 3 weeks since prior biological or immunological agents

Chemotherapy

See Disease Characteristics
At least 3 weeks since prior chemotherapy and recovered
No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen
No prior karenitecin or camptothecin analogue/derivative

Endocrine therapy

At least 1 week since prior hormonal therapy
- Concurrent hormone replacement therapy allowed

Radiotherapy

See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered
No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery

Recovered from recent surgery

Other

At least 3 weeks since prior therapy directed at this malignancy
No prior anticancer therapy that would preclude study therapy
No concurrent amifostine or other protective reagents

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Japan, Norway, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00054119

Responsible Party

Study ID Numbers ^ICMJE

CDR0000269898, GOG-0186D, BIONUM-KTN22307

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	John J. Kavanagh, MD	M.D. Anderson Cancer Center
Investigator:	Judith A. Smith, PharmD, BCOP	M.D. Anderson Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP