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Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas


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

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Trial Information

Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas


OBJECTIVES:

Primary

- Compare the anti-tumor activity, in terms of objective response rate, in patients with
metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma treated with
gemcitabine with vs without docetaxel as second-line therapy.

Secondary

- Compare the progression-free survival of patients treated with these regimens.

- Compare the response duration and overall survival of patients treated with these
regimens.

- Compare the tolerability and dose intensity of these regimens in these patients.

- Determine biological markers with a predictive value for response to these regimens in
these patients.

OUTLINE: This is a randomized study. Patients are stratified according to location of
leiomyosarcoma (uterine vs soft tissue). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive gemcitabine on days 1, 8, and 15. Treatment repeats every 4
weeks for 2-8 courses.

- Arm II: Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8. Treatment
repeats every 3 weeks for 2-8 courses.

PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be
accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed uterine or soft tissue leiomyosarcoma, meeting ≥ 1 of the
following criteria:

- Metastatic disease

- Relapsed and unresectable disease

- Prior treatment with a first-line anthracycline-based chemotherapy regimen required

- Relapsed disease > 1 year after adjuvant chemotherapy is considered untreated
disease

- If relapsed disease occurs < 1 year after adjuvant therapy, then adjuvant
therapy is considered a first-line treatment

- At least 1 measurable lesion, defined as the following:

- At least 1 target lesion must be located in a non-irradiated area

- Obvious disease progression within the past 6 weeks

- No other uterine sarcomas, including any of the following:

- Carcinosarcoma

- Endometrial stroma sarcoma

- Other soft tissue sarcoma

- No symptomatic or known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- WHO 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- No specific hepatic contraindication to study treatment

- Hepatitis B core and hepatitis B surface antigen negative

Renal

- Creatinine < 1.5 times ULN

- No specific renal contraindication to study treatment

Cardiovascular

- No specific cardiac contraindication to study treatment

Immunologic

- HIV negative

- No specific allergic contraindication to study treatment

- No active infection

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other serious underlying pathology that would preclude study treatment

- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the
cervix

- No neurotoxicity > grade 2

- No psychological, sociological, or geographical condition that would preclude study
compliance or follow-up schedule

- No prior or concurrent psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior immunotherapy

- No prior allogeneic graft or autologous graft

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy

- No prior gemcitabine and/or taxane (i.e., docetaxel or paclitaxel)

Endocrine therapy

- More than 4 weeks since prior hormonal therapy

Radiotherapy

- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to the only evaluable lesion

Surgery

- Not specified

Other

- No concurrent participation in another clinical trial using an experimental agent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Anti-tumoral activity (objective response rate)

Safety Issue:

No

Principal Investigator

Florence Duffaud, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CHU de la Timone

Authority:

Unspecified

Study ID:

CDR0000443572

NCT ID:

NCT00227669

Start Date:

October 2005

Completion Date:

Related Keywords:

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

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