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Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboxyamidotriazole
chemotherapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
June 19, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019461
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2003
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboxyamidotriazole
Intervention Type
Drug
Intervention Name(s)
chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahrukh Hussain, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14645425
Citation
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. doi: 10.1200/JCO.2003.04.136.
Results Reference
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Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

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