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

Recurrent Ovarian Carcinoma Clinical Trial

Official title:

A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054119
• Other study ID #: GOG-0186D
• Secondary ID: NCI-2012-02514CD
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: July 12, 2017
• Start date: January 2003

Study information

• Verified date: July 2017
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: September 30, 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Recurrent Ovarian Carcinoma

Intervention

Drug:
• Cositecan
Given IV

Other:
• Pharmacological Study
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group of Arizona	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of objective response		Up to 6 years
Primary	Duration of objective response		Up to 6 years
Primary	Frequency of observed adverse effects, graded according to CTC version 2.0		Up to 6 years
Primary	Severity of observed adverse effects, graded according to CTC version 2.0		Up to 6 years
Primary	Survival time for all patients		Up to 6 years
Primary	Duration of progression-free interval for all patients		Up to 6 years