Know Cancer

or
forgot password

A Multi-Institutional, Open-Label, Two-Group, Phase II Study of PS-341 (LDP-341, NSC #681239) in Patients With Advanced or Metastatic Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A Multi-Institutional, Open-Label, Two-Group, Phase II Study of PS-341 (LDP-341, NSC #681239) in Patients With Advanced or Metastatic Sarcoma


OBJECTIVES:

- Determine the response rate in patients with advanced or metastatic sarcoma treated
with bortezomib.

- Correlate levels of cyclins D1, E, p21 (WAF1), p27 (Kip1), mdm^2, p53, and Ki67 with
response in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
disease (stratum I: soft tissue sarcoma not specified in stratum II, osteogenic sarcoma
arising from soft tissues, or gastrointestinal stromal tumor vs stratum II: Ewing's sarcoma
of soft tissue or bone, rhabdomyosarcoma, or osteogenic sarcoma of bone). (Stratum I closed
to accrual as of 10/17/03.)

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for stratum I within 5-11
months and 21-41 patients will be accrued for stratum II within 10.5-22 months. (Stratum I
closed to accrual as of 10/17/03.)

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed sarcoma

- Soft tissue metastasis or locally recurrent disease

- Stratum I (closed to accrual as of 10/17/03):

- Soft tissue sarcoma not specified in stratum II

- Osteogenic sarcoma arising from soft tissue or gastrointestinal stromal tumor
(GIST)

- Stratum II:

- Ewing's sarcoma of soft tissue or bone (if measurable soft tissue metastasis is
present)

- Rhabdomyosarcoma

- Osteogenic sarcoma of bone (if measurable soft tissue metastasis is present)

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Disease progression within the past 3 months

- No prior or active known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 80-100% OR

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- 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

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

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No peripheral vascular disease requiring surgical management

- No history of congestive heart failure even if it is medically controlled

- No angina pectoris even if it is medically controlled

- No myocardial infarction within the past year

- No cardiac arrhythmias

- No prior cerebrovascular event

- No prior transient ischemic attack

- No EKG evidence of acute ischemia or conduction abnormality (e.g., bifascicular block
[left anterior hemiblock in the presence of right bundle branch block] or second or
third degree atrioventricular block)

- No history of orthostatic hypotension

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior allergic reaction to compounds of similar chemical or biological composition
to study drug

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other malignancy within the past 5 years except adequately treated basal cell skin
cancer or carcinoma in situ of the cervix

- No symptomatic peripheral neuropathy greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent biological or immunological agents

Chemotherapy:

- Stratum I (closed to accrual as of 10/17/03):

- At least 1 year since prior chemotherapy in the adjuvant or neoadjuvant setting

- No other prior chemotherapy

- Stratum II:

- No more than 1 prior chemotherapy regimen

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- Prior imatinib mesylate for GIST (stratum I closed to accrual as of 10/17/03) allowed

- No other concurrent investigational agents

- No concurrent commercial anticancer agents or therapies

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert Maki, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-073

NCT ID:

NCT00027716

Start Date:

October 2001

Completion Date:

May 2004

Related Keywords:

  • Sarcoma
  • metastatic osteosarcoma
  • recurrent adult soft tissue sarcoma
  • recurrent osteosarcoma
  • adult rhabdomyosarcoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • stage IV adult soft tissue sarcoma
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Albert Einstein College of MedicineBronx, New York  10461
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104
University of Chicago Cancer Research CenterNew York, New York  10021