Clinical trial NCT00054119: Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official title: A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-02-06
Enrollment: 27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of objective response
timeFrame: Up to 6 years
measure: Duration of objective response
timeFrame: Up to 6 years
measure: Frequency of observed adverse effects, graded according to CTC version 2.0
timeFrame: Up to 6 years
measure: Severity of observed adverse effects, graded according to CTC version 2.0
timeFrame: Up to 6 years
measure: Survival time for all patients
timeFrame: Up to 6 years
measure: Duration of progression-free interval for all patients
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Gynecologic Oncology Group of Arizona
state: Arizona
Study officials:
affiliation: Gynecologic Oncology Group
name: John Kavanagh
role: PRINCIPAL_INVESTIGATOR
References: