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An Open Label Phase IIa Trial Evaluating The Safety And Efficacy Of EP0906 As Therapy In Patients With Advanced Renal Cancer


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

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Trial Information

An Open Label Phase IIa Trial Evaluating The Safety And Efficacy Of EP0906 As Therapy In Patients With Advanced Renal Cancer


OBJECTIVES:

- Determine whether epothilone B can produce a significant response (complete response
(CR) or partial response (PR)) as measured by tumor shrinkage in patients with advanced
renal cancer.

- Determine the objective response rate and duration of response in patients with CR or
PR after treatment with this drug.

- Determine the time to disease progression and overall survival in patients treated with
this drug.

- Determine the safety and tolerability of this drug in these patients.

- Determine genetic factors related to renal cancer that may predict response in patients
treated with this drug.

- Determine relative susceptibility to drug-drug interactions or serious side effects in
patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive epothilone B IV over 5 minutes once weekly for three weeks. Courses repeat
every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 week and then every three months thereafter.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed epithelial renal cell carcinoma

- Clear cell

- Sarcomatoid

- Papillary

- Medullary

- Collecting duct

- Chromophobe

- Mixed histology

- Progressive regional disease or metastatic disease

- Prior nephrectomy required

- Previously untreated patients or patients who have received no more than one prior
cytokine regimen (interleukin-2, interferon alfa, or a combination of these agents)
and have failed or relapsed within 8 months of treatment

- At least one measurable lesion

- Patients who have received prior radiotherapy to the marker lesion(s) must have
disease progression in that lesion since treatment

- No CNS metastases or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC greater than 3,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

- Hemoglobin greater than 9.0 g/dL

- Platelet count greater than 100,000/mm^3

- Red blood cell transfusions allowed

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)

- Alkaline phosphatase less than 2.5 times ULN

Renal:

- Creatinine less than 1.5 times ULN

Cardiovascular:

- No severe cardiac insufficiency

- No New York Heart Association class III or IV disease

- No uncontrolled and/or unstable cardiac or coronary artery disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after study therapy

- No peripheral neuropathy greater than grade 1

- No unresolved diarrhea greater than grade 1

- No active or suspected acute or chronic uncontrolled infection

- No abscess or fistula

- HIV negative

- No other malignancy within the past 3 years except curatively treated nonmelanoma
skin cancer, prostate cancer, or carcinoma in situ of the cervix

- No prior noncompliance to medical regimens

- No history of severe medical conditions that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery

Other:

- More than 28 days since prior investigational drugs

- No other concurrent investigational drugs

- No concurrent warfarin or other agents containing warfarin except low-dose warfarin
(1 mg or less) administered prophylactically for maintenance of indwelling lines or
ports

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert A. Figlin, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069433

NCT ID:

NCT00041002

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • clear cell renal cell carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781