Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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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 Primary Peritoneal Cavity Cancer |
Drug: carboxyamidotriazole Drug: chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Start Date: | April 1998 |
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 |
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| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Mahrukh Hussain, MD | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00019461 History of Changes |
| Obsolete Identifiers: | NCT00001682 |
| Other Study ID Numbers: | CDR0000066216, NCI-98-C-0012, NCI-T97-0112 |
| Study First Received: | July 11, 2001 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Carboxyamido-triazole Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013