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

NCT ID: NCT00019461

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-04-30
• Study Completion Date: 2007-10-31

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboxyamidotriazole

Intervention Type: DRUG

chemotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Mahrukh Hussain, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 14645425 (View on PubMed)

Other Identifiers

NCI-98-C-0012

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0112

Identifier Type: -

Identifier Source: secondary_id

CDR0000066216

Identifier Type: -

Identifier Source: org_study_id

NCT00001682

Identifier Type: -

Identifier Source: nct_alias