Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112489
First received: June 2, 2005
Last updated: August 17, 2010
Last verified: March 2008
History of Changes
  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 chemotherapy) 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 Intervention Phase
Sarcoma
 Drug: carboplatin
Drug: paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Paclitaxel (Taxol, NSC # 673089) and Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Nature and degree of toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 47
Study Start Date: May 2005
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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 older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 unless there is documented disease progression
  • 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

  • No prior cytotoxic chemotherapy for uterine sarcoma

Endocrine therapy

  • At least 1 week since prior hormonal therapy for uterine sarcoma
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • No prior anticancer therapy that would preclude study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112489

  Show 110 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Matthew A. Powell, MD Washington University Siteman Cancer Center
Investigator: Dennis R. Scribner, MD Carilion Gynecologic Oncology Associates
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Powell MA, Filiaci VL, Rose PG, et al.: A phase II evaluation of paclitaxel and carboplatin in the treatment of carcinosarcoma of the uterus: A Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 27 (Suppl 15): A-5515, 2009.

ClinicalTrials.gov Identifier: NCT00112489     History of Changes
Other Study ID Numbers: CDR0000432956, GOG-0232B
Study First Received: June 2, 2005
Last Updated: August 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
uterine carcinosarcoma

Additional relevant MeSH terms:
Carcinosarcoma
Sarcoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue
Carboplatin
Paclitaxel
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013