Chemotherapy in Treating Patients With Unresectable Primary or Metastatic Kidney Cancer

NCT00003714 | Withdrawn Phase 2

• 6 other identifiers: DM98-107P30CA016672U01CA070172MDA-DM-98107NCI-T98-0031CDR0000066822
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 pyrazoloacridine in treating patients who have unresectable primary or metastatic kidney cancer that has not been previously treated.

Conditions

Liver Cancer; Metastatic Cancer

Keywords

localized unresectable adult primary liver cancer; advanced adult primary liver cancer; adult primary hepatocellular carcinoma; liver metastases

Outcome Measures

Primary Outcomes (1)

• Patient Response

  6 weeks

Study Arms (1)

Pyrazoloacridine

EXPERIMENTAL

Drug: Pyrazoloacridine

Interventions

Pyrazoloacridine DRUG

IV (by vein) over 3 hours every 3 weeks

Also known as: PZA

Pyrazoloacridine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis; Carcinoma, Hepatocellular

Interventions

NSC 366140

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Yehuda Z. Patt, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 14, 2004
• Last Updated: February 22, 2012

Record last verified: 2012-02