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Phase II Trial of PS341 (NSC 681239) in Patients With Advanced Renal Cell Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

Phase II Trial of PS341 (NSC 681239) in Patients With Advanced Renal Cell Carcinoma


OBJECTIVES:

- Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma.

- Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats
every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Metastatic disease

- Unidimensionally measurable disease

- No brain metastases

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Karnofsky 70-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- ALT/AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- No pre-existing neuropathy of grade 1 or greater

- No other malignancy within the past 5 years, except completely resected basal cell
skin cancer, unless treated with potentially curative therapy or at low risk for
recurrence

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 4 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy and recovered

- No concurrent biologic therapy

Chemotherapy:

- No prior cytotoxic therapy

- No concurrent cytotoxic therapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- At least 4 weeks since prior major surgery

Other:

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Beverly Drucker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068678

NCT ID:

NCT00017329

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021