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A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer


OBJECTIVES:

- Determine the antitumor activity of nitrocamptothecin in patients with recurrent or
metastatic ovarian epithelial or primary peritoneal cancer.

- Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive oral nitrocamptothecin on days 1-5. Treatment continues every 7
days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks, then every 3 months for 2 years, and then every 6 months
for 3 years.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 22
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or metastatic ovarian epithelial or primary
peritoneal cancer

- Measurable disease

- Ascites and pleural effusions are not considered measurable

- Sonography allowed if bidimensionally measurable

- Must not be eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Granulocyte count at least 1,500/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT and alkaline phosphatase no greater than 3 times ULN

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- No other prior or concurrent invasive malignancy in the past 5 years except
nonmelanoma skin cancer

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least but no more than 2 prior chemotherapy regimens containing carboplatin,
cisplatin, or another organoplatinum compound combined with paclitaxel

- Second line therapy may include any agents except topoisomerase I inhibitors (i.e.,
topotecan)

- No prior nitrocamptothecin or topoisomerase I inhibitors

- At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- At least 3 weeks since prior surgery and recovered

Other:

- No prior cancer therapy that contraindicates this study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Edward C. Grendys, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068210

NCT ID:

NCT00006267

Start Date:

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

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