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Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
This study has been completed.
Study NCT00019461   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
April 1998
 
 
 
Complete list of historical versions of study NCT00019461 on ClinicalTrials.gov Archive Site
 
 
 
Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Phase II Trial of Orally Administered CAI for Patients With Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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.

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.

Phase II
Interventional
Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Drug: carboxyamidotriazole
  • Drug: chemotherapy
 
Hussain MM, Kotz H, Minasian L, Premkumar A, Sarosy G, Reed E, Zhai S, Steinberg SM, Raggio M, Oliver VK, Figg WD, Kohn EC. Phase II trial of carboxyamidotriazole in patients with relapsed epithelial ovarian cancer. J Clin Oncol. 2003 Dec 1;21(23):4356-63.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019461
 
CDR0000066216, NCI-98-C-0012, NCI-T97-0112
National Cancer Institute (NCI)
 
Study Chair: Mahrukh Hussain, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP