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OpenTrials
Completed

NCT Number: NCT00019461

Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboxyamidotriazole

Drug

Chemotherapy

Drug

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study 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

Important dates

Study start
1998
Study completion
2007
First posted
Jan 27, 2003
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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