Brief Title
Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Phase II Trial of Orally Administered CAI for Patients With Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating
patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary
peritoneal cancer.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
carboxyamidotriazole
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
April 1998
Completion Date
October 2007
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mahrukh Hussain, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00019461
Organization ID
CDR0000066216
Secondary IDs
NCI-98-C-0012
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Mahrukh Hussain, MD, Study Chair, National Cancer Institute (NCI)
Verification Date
June 2003