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A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

Phase 2
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma


- Determine the antitumor activity of karenitecin in patients with persistent or
recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.

- 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 .

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22

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



- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified


- 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


Biologic therapy

- 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

Endocrine therapy

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John J. Kavanagh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



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