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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITissue collection/Repository, TreatmentClosed18 and overNCI, OtherGOG-0261
NCI-2011-01959, CDR0000651458, U10CA027469, U10CA180868, NCT00954174

Trial Description

Summary

This randomized phase III trial studies paclitaxel and carboplatin see how well it works compared with paclitaxel and ifosfamide in treating patients with newly diagnosed persistent or recurrent uterine, ovarian, fallopian tube, or peritoneal 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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritoneal 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 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.

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 and an enrollment date prior to 10/21/2013; 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 greater than or equal to 100,000/mcL
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL equivalent to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 1
  • Creatinine less than or equal to 1.5 times upper limit of normal (ULN), CTCAE v3.0 grade 1
  • Bilirubin less than or equal to 1.5 times ULN (CTCAE v3.0 grade 1)
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 times ULN (CTCAE v3.0 grade 1)
  • Alkaline phosphatase less than or equal to 2.5 times ULN (CTCAE v3.0 grade 1)
  • Serum albumin should be equal to or greater than 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
  • For enrollment prior to 10/21/2013, patients who are not biopsy proven to have carcinosarcoma of the uterus, fallopian tube, peritoneum or ovary; for enrollment after 10/21/2013, patients who are not biopsy proven to have carcinosarcoma of the uterus

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

  • National Cancer Institute
Matthew Powell, Principal 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

Palo Alto

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

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00954174
ClinicalTrials.gov processed this data on April 09, 2015

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.