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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 2

Conditions

Primary Peritoneal Carcinoma

Recurrent Ovarian Carcinoma

Treatments

Drug: Cositecan

Other: Pharmacological Study

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00054119

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000269898

NCI-2012-02514 (Registry Identifier)

BIONUM-KTN22307

GOG-0186D (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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