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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00112489
First received: June 2, 2005
Last updated: April 11, 2014
Last verified: April 2014
  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: Intervention Model: Single Group Assignment
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:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Nature and Degree of Toxicity [ Time Frame: During study treatment and up to 30 days after stopping study treatment ] [ Designated as safety issue: Yes ]
    Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0

  • Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response [ Time Frame: Response was measured every other cycle (q 6 weeks) until disease progression is documented. ] [ Designated as safety issue: No ]

    Primary outcome measured according to RECIST v1.0 Best Response:

    Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.



Enrollment: 55
Study Start Date: May 2005
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Taxol-Carbo
Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy
Drug: carboplatin Drug: paclitaxel

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112489

  Show 110 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Matthew A. Powell, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
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.

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00112489     History of Changes
Other Study ID Numbers: CDR0000432956, GOG-0232B
Study First Received: June 2, 2005
Results First Received: April 11, 2014
Last Updated: April 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
uterine carcinosarcoma

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

ClinicalTrials.gov processed this record on September 18, 2014