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

A Phase II Evaluation of Karenitecin 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.

Study Overview

• Status: Completed
• Conditions: Recurrent Ovarian Carcinoma; Primary Peritoneal Carcinoma
• Intervention / Treatment: Other: Pharmacological Study; Drug: Cositecan

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Gynecologic Oncology Group of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Pharmacological Study; Correlative studies; Other Names: pharmacological studies; Drug: Cositecan; Given IV; Other Names: BNP1350; DB 172; Karenitecin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: John Kavanagh, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): September 30, 2005

Study Registration Dates

• First Submitted: February 5, 2003
• First Submitted That Met QC Criteria: February 5, 2003
• First Posted (Estimate): February 6, 2003

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Carcinoma; Recurrence
• Other Study ID Numbers: GOG-0186D (Other Identifier: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2012-02514 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CDR0000269898; BIONUM-KTN22307