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
  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 Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: karenitecin
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: January 2003
Primary Completion Date: March 2004 (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: karenitecin
Given IV
Other Name: BNP1350
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

Genders 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
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, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: John Kavanagh Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00054119     History of Changes
Other Study ID Numbers: GOG-0186D, NCI-2012-02514, CDR0000269898, BIONUM-KTN22307, GOG-0186D, GOG-0186D, U10CA027469
Study First Received: February 5, 2003
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014