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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:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00054119
First received: February 5, 2003
Last updated: February 12, 2014
Last verified: February 2014

February 5, 2003
February 12, 2014
January 2003
March 2004   (final data collection date for primary outcome measure)
  • Frequency of objective response [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Frequency of observed adverse effects, graded according to CTC version 2.0 [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
  • Severity of observed adverse effects, graded according to CTC version 2.0 [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
  • Survival time for all patients [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Duration of progression-free interval for all patients [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00054119 on ClinicalTrials.gov Archive Site
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Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Drug: karenitecin
    Given IV
    Other Name: BNP1350
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
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.
Interventions:
  • Drug: karenitecin
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
March 2004   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054119
GOG-0186D, NCI-2012-02514, CDR0000269898, BIONUM-KTN22307, GOG-0186D, GOG-0186D, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: John Kavanagh Gynecologic Oncology Group
Gynecologic Oncology Group
February 2014

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