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A Phase II Trial of Orally Administered CAI for Patients With Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase II Trial of Orally Administered CAI for Patients With Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer


OBJECTIVES:

- Determine the clinical outcome in patients with ovarian epithelial, fallopian tube, or
primary peritoneal cancer treated with carboxyamidotriazole.

OUTLINE: Patients receive oral carboxyamidotriazole daily beginning on day 1. Treatment
continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed refractory or recurrent ovarian epithelial, fallopian tube,
or primary peritoneal cancer

- Measurable disease by physical exam, radiography, peritoneoscopy, or laparoscopy

- No more than 4 weeks since prior peritoneoscopy

- No brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 4 months

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm^3

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

- Hemoglobin at least 9.0 g/dL AND/OR

- Hematocrit at least 27%

Hepatic:

- SGOT/SGPT no greater than 3 times upper limit of normal

- Bilirubin normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular:

- No history of symptomatic cardiac dysrhythmias requiring medication

- At least 6 months since prior myocardial infarction

- No unstable or newly diagnosed angina

Pulmonary:

- No obstructive lung disease requiring oxygen therapy

Other:

- Not pregnant or nursing

- HIV negative

- Must be able to take oral medication

- No concurrent medical condition (e.g., impending bowel obstruction)

- No grade 2 or greater residual peripheral neuropathy

- No active infection

- No other prior or concurrent invasive malignancy within the past 5 years

- No history of acute visual loss other than that associated with retinal detachment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior cytokine therapy

- No concurrent cytokine therapy to maintain WBC count

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, or
mitomycin)

- No other concurrent chemotherapy

Endocrine therapy:

- At least 4 weeks since prior hormonal therapy

- No concurrent corticosteroids at doses greater than physiological replacement doses

- No concurrent hormonal therapy

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No more than 3 prior treatment regimens

- At least 1 week since prior systemic antibiotics for infection

- No chronic antifungal treatment with antimycotic imidazoles

- No concurrent alternative therapies

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mahrukh Hussain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000066216

NCT ID:

NCT00019461

Start Date:

April 1998

Completion Date:

October 2007

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182