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

Phase 2

Completed

• Conditions: Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma
• Interventions: Drug: Cositecan; Other: Pharmacological Study

• Registration Number: NCT00054119
• Lead Sponsor: Gynecologic Oncology Group

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Primary Completion: 2005-09-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Cositecan	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.
Treatment	Pharmacological 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.

Primary Outcome Measures

Name	Time	Method
Frequency of objective response	Up to 6 years
Duration 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

Trial Locations

Locations (1)

Gynecologic Oncology Group of Arizona; 🇺🇸 Phoenix, Arizona, United States