NCT00019461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2003

First QC Date

July 11, 2001

Last Update Submit

June 19, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

carboxyamidotriazoleDRUG
chemotherapyDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • 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.

    PMID: 14645425RESULT

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

carboxyamido-triazoleDrug Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mahrukh Hussain, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

April 1, 1998

Study Completion

October 1, 2007

Last Updated

June 20, 2013

Record last verified: 2003-06

Locations

US(1)