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A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma


OBJECTIVES:

- Determine the efficacy of temozolomide and thalidomide in patients with metastatic,
locally advanced, or unresectable leiomyosarcoma.

- Determine the time to progression in patients treated with this regimen.

- Determine the overall survival of patients treated with this regimen.

- Determine the clinical and laboratory toxic effects and tolerability of this regimen in
these patients.

OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral
thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease
progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed leiomyosarcoma

- Metastatic, locally advanced, or unresectable

- Ineligible for other high priority national or institutional study

- At least 1 unidimensionally measurable lesion documented on radiologic study

- At least 2 cm by 2 cm

- Not previously irradiated unless disease progression at the site is evident

- No brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- More than 2 months

Hematopoietic:

- WBC greater than 3,000/mm^3

- Neutrophil count at least 1,500/mm^3

- Platelet count greater than 70,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin less than upper limit of normal (ULN)

- SGOT or SGPT less than 1.5 times ULN*

- Alkaline phosphatase less than 2 times ULN* NOTE: * Less than 5 times ULN if
documented liver disease

Renal:

- Creatinine less than 1.5 times normal OR

- Creatinine clearance greater than 60 mL/min

- BUN less than 1.5 times normal

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 forms of effective contraception for 4 weeks before,
during, and for 4 weeks after study therapy

- No acute infection requiring systemic antibiotics

- No frequent vomiting or medical condition that would preclude intake of oral
medication (e.g., partial bowel obstruction)

- No other serious medical or psychiatric illness that would preclude study
participation

- No prior malignancy except curatively treated carcinoma in situ of the cervix or skin
cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 4 weeks since prior chemotherapy

- No more than 3 prior systemic chemotherapy regimens for metastatic, locally advanced,
or unresectable leiomyosarcoma

- Prior dacarbazine allowed

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to 50% or more of bone marrow

- Concurrent radiotherapy for local control or palliative therapy for painful bony or
soft tissue lesion allowed

Surgery:

- At least 4 weeks since prior surgery and recovered

Other:

- Recovered from all prior therapies

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response (complete and partial response)

Safety Issue:

No

Principal Investigator

Robert N. Taub, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069314

NCT ID:

NCT00033709

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Sarcoma
  • adult leiomyosarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • uterine leiomyosarcoma
  • stage IV adult soft tissue sarcoma
  • Leiomyosarcoma
  • Sarcoma

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032