Trial record 10 of 55 for:    Carcinosarcoma

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00954174
First received: August 6, 2009
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Carcinosarcoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Recurrent Uterine Corpus Sarcoma
Stage I Ovarian Cancer
Stage IA Fallopian Tube Cancer
Stage IA Ovarian Cancer
Stage IA Uterine Sarcoma
Stage IB Fallopian Tube Cancer
Stage IB Ovarian Cancer
Stage IB Uterine Sarcoma
Stage IC Fallopian Tube Cancer
Stage IC Ovarian Cancer
Stage IC Uterine Sarcoma
Stage II Ovarian Cancer
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Cancer
Stage IIA Uterine Sarcoma
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Cancer
Stage IIB Uterine Sarcoma
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIA Uterine Sarcoma
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIB Uterine Sarcoma
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Stage IIIC Uterine Sarcoma
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Carcinosarcoma
Drug: Paclitaxel
Drug: Carboplatin
Drug: Ifosfamide
Other: Quality-of-Life Assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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, Fallopian Tube, Peritoneum or Ovary

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Assessed using a stratified Cox proportional hazards model.

  • Incidence of adverse events as assessed by CTCAE version 3.0 [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
    The maximum grade over the entire course of therapy for any individual effect will be used as a summary of acute toxicity. The Kruskal-Wallis test corrected for ties will be used to compare the maximum grade of acute adverse effects of therapy by treatment arm.

  • Quality of life measured using the Functional Assessment of Cancer Therapy (FACT)-general, Physical Well-being and Functional Well-being subscales, FACT-endometrial, and FACT/GOG-NTtx subscale [ Time Frame: Up to 30 weeks following initiation of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 603
Study Start Date: August 2009
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (paclitaxel, carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Experimental: Arm II (paclitaxel, ifosfamide)
Patients receive paclitaxel as in Arm I and ifosfamide IV over 1 hour on days 1-3.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Ifosfamide
Given IV
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00954174

  Show 538 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Matthew Powell NRG Oncology
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00954174     History of Changes
Other Study ID Numbers: GOG-0261, NCI-2011-01959, CDR0000651458, GOG-0261, GOG-0261, U10CA027469, U10CA180868
Study First Received: August 6, 2009
Last Updated: December 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinosarcoma
Mixed Tumor, Mullerian
Carcinoma
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Sarcoma
Uterine Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Uterine Diseases
Carboplatin
Ifosfamide

ClinicalTrials.gov processed this record on August 03, 2015