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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.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019461
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboxyamidotriazole
Procedure: chemotherapy
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   L 651582   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 1998

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019461

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Mahrukh Hussain, MD     NCI - Center for Cancer Research-Medical Oncology    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000066216, NCI-98-C-0012, NCI-T97-0112
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00019461
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer  
fallopian tube cancer  
peritoneal cavity cancer  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Carboxyamido-triazole
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Endocrinopathy
Fallopian tube cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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