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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00054119
First Posted: February 6, 2003
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Condition Intervention Phase
Primary Peritoneal Carcinoma Recurrent Ovarian Carcinoma Drug: Cositecan Other: Pharmacological Study Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Frequency of objective response [ Time Frame: Up to 6 years ]
  • Duration of objective response [ Time Frame: Up to 6 years ]
  • Frequency of observed adverse effects, graded according to CTC version 2.0 [ Time Frame: Up to 6 years ]
  • Severity of observed adverse effects, graded according to CTC version 2.0 [ Time Frame: Up to 6 years ]
  • Survival time for all patients [ Time Frame: Up to 6 years ]
  • Duration of progression-free interval for all patients [ Time Frame: Up to 6 years ]

Enrollment: 27
Study Start Date: January 2003
Primary Completion Date: September 30, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
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.
Drug: Cositecan
Given IV
Other Names:
  • BNP1350
  • DB 172
  • Karenitecin
Other: Pharmacological Study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

OBJECTIVES:

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

II. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • 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
  • Creatinine no greater than 1.5 times ULN
  • 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
  • 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
  • At least 3 weeks since prior biological or immunological agents
  • 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
  • At least 1 week since prior hormonal therapy

    • Concurrent hormone replacement therapy allowed
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • Recovered from recent surgery
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054119


Locations
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: John Kavanagh Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00054119     History of Changes
Other Study ID Numbers: GOG-0186D
NCI-2012-02514 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000269898
BIONUM-KTN22307
GOG-0186D ( Other Identifier: Gynecologic Oncology Group )
GOG-0186D ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 5, 2003
First Posted: February 6, 2003
Last Update Posted: July 13, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action