Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Sarcoma |
Drug: carboplatin Drug: ifosfamide Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naive Patients With Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary |
- Duration of overall survival [ Designated as safety issue: No ]
- Duration of progression-free survival [ Designated as safety issue: No ]
- Toxicity as assessed by CTCAE version 3.0 [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
| Estimated Enrollment: | 424 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm II
Patients receive paclitaxel as in arm I and ifosfamide IV over 1 hour on days 1-3.
|
Drug: ifosfamide
Given IV
Drug: paclitaxel
Given IV
|
Detailed Description:
OBJECTIVES:
Primary
- To determine if treatment with paclitaxel and carboplatin does not result in an inferior death rate when compared to paclitaxel and ifosfamide in chemotherapy-naïve patients with newly diagnosed stage I-IV persistent or recurrent uterine or ovarian carcinosarcoma.
Secondary
- To determine if treatment with combination paclitaxel and carboplatin does not result in an inferior progression-free survival when compared to paclitaxel and ifosfamide.
- To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin is reduced compared to that of paclitaxel and ifosfamide.
- To determine if treatment with combination paclitaxel and carboplatin is associated with superior patient reported quality of life and neurotoxicity scores compared to that of paclitaxel and ifosfamide.
Tertiary
- To bank formalin-fixed and paraffin-embedded tumor tissue and DNA extracted from whole blood specimens for future research.
OUTLINE: Patients are stratified according to history of pelvic radiation (any vs none), disease status/stage at time of study registration (stage I-II [pelvic lymph nodes not surgically and pathologically assessed] vs FIGO stage I-II [pelvic lymph nodes surgically and pathologically assessed] vs FIGO stage III-IV vs recurrent), and measurable disease (any vs none). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.
- Arm II: Patients receive paclitaxel as in arm I and ifosfamide IV over 1 hour on days 1-3.
In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity.
Archival formalin-fixed and paraffin-embedded tumor tissue samples and a pre-treatment blood sample are collected for further analysis. Patients also complete quality of life (FACT-G, FACT-En TOI) and neurotoxicity (FACT/GOG-Ntx subscale) assessments at baseline and at weeks 6, 15, and 26.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 362 Study Locations| Study Chair: | Matthew A. Powell, MD | Washington University Siteman Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00954174 History of Changes |
| Other Study ID Numbers: | CDR0000651458, GOG-0261 |
| Study First Received: | August 6, 2009 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
uterine carcinosarcoma ovarian carcinosarcoma stage I uterine sarcoma stage II uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma recurrent uterine sarcoma recurrent ovarian epithelial cancer stage IA ovarian epithelial cancer |
stage IB ovarian epithelial cancer stage IC ovarian epithelial cancer stage IIA ovarian epithelial cancer stage IIB ovarian epithelial cancer stage IIC ovarian epithelial cancer stage IIIA ovarian epithelial cancer stage IIIB ovarian epithelial cancer stage IIIC ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Carcinosarcoma Mixed Tumor, Mullerian Ovarian Neoplasms Sarcoma Neoplasms, Complex and Mixed Neoplasms by Histologic Type Neoplasms Neoplasms, Connective and Soft Tissue Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Ifosfamide Isophosphamide mustard Carboplatin Paclitaxel Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 19, 2013