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

NCT ID: NCT00054119

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31

Brief 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.

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.

Conditions

Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cositecan

Intervention Type: DRUG

Given IV

Pharmacological Study

Intervention Type: OTHER

Correlative studies

Interventions

Cositecan

Given IV

Intervention Type: DRUG

Pharmacological Study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

BNP1350; DB 172; Karenitecin; pharmacological studies

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Kavanagh

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

NCI-2012-02514

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000269898

Identifier Type: -

Identifier Source: secondary_id

BIONUM-KTN22307

Identifier Type: -

Identifier Source: secondary_id

GOG-0186D

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0186D

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0186D

Identifier Type: -

Identifier Source: org_study_id