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Gynecologic Cancer

Paclitaxel + Carboplatin vs Ifosfamide + Paclitaxel for Uterine or Ovarian Cancer (GOG 0261)
A Randomized Phase III Trial of Paclitaxel plus Carboplatin versus Ifosfamide plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary
Status Conditions Phase Study ID
Closed Gynecological Cancer; Ovarian Cancer; Solid Tumors; Uterine Cancer Phase III GOG+0261
NCT00954174
Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether paclitaxel is more effective when given together with carboplatin or ifosfamide in treating patients with uterine or ovarian cancer.

PURPOSE: This randomized phase III trial is studying giving paclitaxel together with carboplatin to see how well it works compared with giving paclitaxel together with ifosfamide in treating patients with newly diagnosed persistent or recurrent uterine or ovarian cancer.


Investigator
Benjamin Greer, MD
Location    
PSOC Office 206-667-5152  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)

 

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Biopsy confirmed uterine (malignant mixed müllerian tumor) or ovarian carcinosarcoma meeting ≥ 1 of the following criteria:

    • Newly diagnosed disease
    • Stage I-IV* disease
    • Persistent or recurrent disease
    • Chemotherapy-naive disease NOTE: *Unstaged patients (patients who have not had hysterectomy surgery) are eligible and should be included as "unstaged" if the only histologic (pathology) documentation of the disease is a biopsy or curettage of the uterus or ovary; if these patients have documented metastatic disease, it should be assigned the appropriate stage (III/IV)
  • Measurable or nonmeasurable disease

    • Measurable disease is defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques (e.g., palpation, plain s-ray, CT scan, MRI) or ≥ 10 mm by spiral CT scan
    • Patients with measurable disease must have ≥ 1 "target lesion" to be used to assess disease progression as defined by RECIST criteria
    • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy

PATIENT CHARACTERISTICS:

  • GO performance status 0-2
  • Platelet count ≥ 100,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Serum albumin ≥ 3 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Neuropathy (sensory and motor) ≤ CTCAE v3.0 grade 1
  • No active infection requiring antibiotics
  • No concurrent or history of other invasive malignancies, except for nonmelanoma skin cancer, within the past 5 years
  • No known hypersensitivity to E. coli-derived drug preparations (pegfilgrastim and filgrastim [G-CSF]), mesna, or other thiol compounds

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from the effects of recent surgery, radiotherapy, or other therapy
  • No prior cytotoxic chemotherapy for management of uterine or ovarian carcinosarcoma
  • No prior cancer treatment that contraindicates this protocol therapy
  • At least 4 weeks since prior adjuvant external beam radiotherapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor

    • Continuation of hormone replacement therapy allowed
  • No planned radiotherapy after or during study treatment prior to progression of cancer
Last Updated
May 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.