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

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054119

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Cavity Cancer	Drug: karenitecin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Karenitecin

U.S. FDA Resources

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

Study Start Date:	January 2003
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054119

Show 59 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

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

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]

Study ID Numbers:	CDR0000269898, GOG-0186D, BIONUM-KTN22307
Study First Received:	February 5, 2003
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00054119 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:

Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009