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Clinical Trials (PDQ®)

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritorium Cavity Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITissue collection/Repository, TreatmentClosed18 and overNCI, OtherGOG-0261
NCI-2011-01959, CDR0000651458, U10CA027469, NCT00954174

Trial Description

Summary

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, ovarian, fallopian tube, or peritorium cavity cancer. 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, ovarian, fallopian tube, or peritorium cavity cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy.

SECONDARY OBJECTIVES:

I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior progression-free survival when compared to ifosfamide, mesna, and paclitaxel chemotherapy.

II. To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin chemotherapy is reduced compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.

III. To determine if treatment with combination paclitaxel and carboplatin chemotherapy is associated with superior patient-reported quality of life and neurotoxicity scores compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.

TERTIARY OBJECTIVES:

I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and deoxyribonucleic acid (DNA) extracted from whole blood 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 Federation of Gynecology and Obstetrics [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 intravenously (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 Criteria

Inclusion Criteria:

  • Patients must have newly diagnosed Stage I-IV, persistent or recurrent (including unstaged) uterine carcinosarcoma (malignant mixed mullerian tumor-MMMT or with ovarian, fallopian tube or peritoneal carcinosarcoma ; pathology confirmed by site/institutional pathologist prior to enrollment) and be chemotherapy naïve as directed against their carcinosarcoma; unstaged patients (patients who have not had hysterectomy or ovarian 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; if these patients have documented metastatic disease, it should be assigned the appropriate Stage (III/IV)
  • Patients may have received prior adjuvant external beam radiation therapy and/or vaginal brachytherapy; patients should be at least 4 weeks from the completion of external beam radiotherapy prior to beginning protocol chemotherapy; patients do not need to be delayed if receiving vaginal brachytherapy only
  • Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
  • Patients must have recovered from the effects of recent surgery, radiotherapy, or other therapy
  • Patients must be free of active infection requiring antibiotics
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to beginning protocol chemotherapy; continuation of hormone replacement therapy is permitted
  • Platelet count >= 100,000/mcL
  • Absolute neutrophil count (ANC) >= 1,500/mcL equivalent to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade 1
  • Creatinine =< 1.5 times upper limit of normal (ULN)
  • Bilirubin =< 1.5 times ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times ULN
  • Alkaline phosphatase =< 2.5 times ULN
  • Serum albumin >= 3 g/dL
  • Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 Grade 1
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
  • Patients may have measurable disease or non-measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT; measurable disease patients must have at least one "target lesion" to be used to assess progression on this protocol as defined by Response Evaluation Criteria In Solid Tumors (RECIST); 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 at least 90 days following completion of radiation therapy

Exclusion Criteria:

  • Patients who have received prior cytotoxic chemotherapy for management of uterine or ovarian carcinosarcoma
  • Patients with a history of other invasive malignancies or with a concomitant invasive malignancy, with the exception of non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last five years; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy
  • Patients for whom radiotherapy is planned after or during chemotherapy prior to progression of cancer
  • Patients with known hypersensitivity to E. coli-derived drug preparations (pegfilgrastim and filgrastim [G-CSF])
  • Patients with a known hypersensitivity to mesna or other thiol compounds
  • Patients who are not biopsy proven to have carcinosarcoma of the uterus, fallopian tube, peritoneum or ovary are ineligible

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Matthew PowellPrincipal Investigator

Trial Sites

U.S.A.
California
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Scott E. Lentz Ph: 626-564-3455
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Bobbie J Rimel Ph: 310-423-8965
  Email: info@ccadmin.wustl.edu
  Stanford
 Stanford Cancer Center
 Jonathan S. Berek Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
Florida
  Fort Myers
 Florida Gynecologic Oncology - Fort Myers
 Edward C. Grendys Ph: 800-874-7502
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Richard A. Boothby Ph: 863-904-1900
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
Michigan
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Fergus Falls
 Lake Region Healthcare Corporation-Cancer Care
 Preston D. Steen Ph: 701-234-6161
New York
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Veena S John Ph: 516-562-3467
  New Hyde Park
 Long Island Jewish Medical Center
 Veena S John Ph: 516-562-3467
 Monter Cancer Center of the North Shore-LIJ Health System
 Veena S John Ph: 516-562-3467
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Parviz Hanjani Ph: 215-481-2402
South Carolina
  Anderson
 AnMed Cancer Center
 David Griffin Ph: 864-512-1000
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Maria C. Bell Ph: 218-333-5000
 Maria C. Bell Ph: 218-333-5000
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
 Marta A Crispens Ph: 800-811-8480

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00954174
ClinicalTrials.gov processed this data on September 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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