Chemotherapy in Treating Patients With Unresectable Primary or Metastatic Kidney 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 pyrazoloacridine in treating patients who have unresectable primary or metastatic kidney cancer that has not been previously treated.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer Metastatic Cancer |
Drug: Pyrazoloacridine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Pyrazoloacridine (PZA) in Previously Untreated Hepatocellular Carcinoma (HCC) Patients |
- Patient Response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pyrazoloacridine |
Drug: Pyrazoloacridine
IV (by vein) over 3 hours every 3 weeks
Other Name: PZA
|
Detailed Description:
OBJECTIVES: I. Determine the response rate, duration, and survival in previously untreated patients with hepatocellular carcinoma treated with pyrazoloacridine (PZA). II. Determine the nature, degree, and duration of toxic effects of PZA in these patients.
OUTLINE: Patients receive pyrazoloacridine IV over 3 hours every 3 weeks. The minimum treatment period is 2 courses with tumor restaging at 6 weeks. Patients with complete remission (CR) or partial remission (PR) may continue on treatment until refractory (PR) or for at least 3 additional courses (CR). Patients with stable disease continue on therapy for at least 2 more courses. Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 24 months.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven unresectable primary or metastatic hepatocellular carcinoma Measurable disease by CT or MRI scan No tense ascites Brain metastases allowed with proper treatment
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Albumin at least 3 g/dL Alkaline phosphatase no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No significant infection Peripheral neurologic toxicity limited to paresthesia and decreased vibratory sense without motor weakness allowed Constipation managed with laxatives without evidence of bowel obstruction allowed No psychological disorders including delirium, confusion, suicidal ideation, or untreated depression
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior palliative radiotherapy allowed At least 3 weeks since prior radiotherapy and recovered Surgery: Recovered from any prior surgery
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003714 History of Changes |
| Other Study ID Numbers: | DM98-107, P30CA016672, U01CA070172, MDA-DM-98107, NCI-T98-0031, CDR0000066822 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
localized unresectable adult primary liver cancer advanced adult primary liver cancer adult primary hepatocellular carcinoma liver metastases |
Additional relevant MeSH terms:
|
Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Neoplastic Processes |
Pathologic Processes Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type NSC 366140 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013