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Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or IV Uterine Cancer - Article


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Clinical Trial: Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or IV Uterine Cancer

This study is not yet open for patient recruitment.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination therapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.

Condition Treatment or Intervention Phase
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
uterine carcinosarcoma
 Drug: carboplatin
 Drug: paclitaxel
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Muscle Disorders;   Soft Tissue Sarcoma;   Uterine Cancer;   Uterine Fibroids

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Paclitaxel and Carboplatin in Patients With Persistent or Recurrent Stage III or IV Uterine Carcinosarcoma

Further Study Details: 

OBJECTIVES:

  • Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor)
  • Stage III or IV disease
  • Persistent or recurrent disease
  • Documented disease progression
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • At least 1 target lesion
  • Tumors within a previously irradiated field are not considered target lesions
  • Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population)

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No sensory or motor neuropathy > grade 1

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

Endocrine therapy

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • No prior anticancer therapy that would preclude study therapy

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00112489


Study chairs or principal investigators

Matthew Powell, MD,  Study Chair,  Barnes-Jewish Hospital   
Dennis R. Scribner, MD,  Carilion Gynecologic Oncology Associates   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000432956; GOG-0232B
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112489
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07


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