Trial record 6 of 19 for:    "Ovarian carcinosarcoma"

Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00085358
First received: June 10, 2004
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

This phase I trial is studying the side effects and best dose of intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer). Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells


Condition Intervention Phase
Brenner Tumor
Fallopian Tube Cancer
Ovarian Carcinosarcoma
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Primary Peritoneal Cavity Cancer
Stage II Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: docetaxel
Biological: bevacizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Intravenous Paclitaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel and CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) in Patients With Previously Untreated Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of IV paclitaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • MTD of IV docetaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • MTD of IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events in patients given IV paclitaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events in patients given of IV docetaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events in patients given IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2004
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (carboplatin, paclitaxel, docetaxel, bevacizumab)

Patients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: carboplatin
Given intraperitoneally
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
Given IV or intraperitoneally
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

Detailed Description:

OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when given in combination with IV paclitaxel followed by IP paclitaxel in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma.

II. Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP paclitaxel in these patients.

III. To determine the feasibility of the combination of IV paclitaxel, IP carboplatin and IV bevacizumab on day one followed by IP paclitaxel on day eight (Part C Only).

IV. Determine the dose-limiting toxic effects and complications in patients treated with these regimens.

V. Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4 assessment tool to determine dose reduction in these patients.

VI. Evaluate the techniques used for intraperitoneal catheter placement, surgical procedures, and reporting of outcomes in these patients.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal (IP) carboplatin.

Patients in the dose-escalation phase are not eligible to enter the feasibility phase.

DOSE-ESCALATION PHASE (PART A or PART B): Patients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

FEASIBILITY PHASE (PART C): Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed fallopian tube, ovarian epithelial, or primary peritoneal carcinoma

    • Stage II-IV disease
    • The following epithelial cell types are allowed:

      • Carcinosarcoma
      • Serous adenocarcinoma
      • Endometrioid adenocarcinoma
      • Mucinous adenocarcinoma
      • Undifferentiated carcinoma
      • Clear cell adenocarcinoma
      • Mixed epithelial carcinoma
      • Transitional cell carcinoma
      • Malignant Brenner's tumor
      • Adenocarcinoma not otherwise specified
  • Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks

    • Optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery
    • Must have a procedure for determining diagnosis of ovarian/peritoneal carcinoma with appropriate tissue for histologic evaluation
  • Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met:

    • Stage ≤ IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary serous)
  • No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
  • No CNS disease (e.g., seizures not controlled with standard medical therapy) or metastasis
  • GOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) (applies to part C only)
  • PTT < 1.2 times the upper limit of normal (applies to part C only)
  • SGOT ≤ 2.5 times normal
  • Alkaline phosphatase ≤ 2.5 times normal
  • Bilirubin ≤ 1.5 times normal
  • Creatinine ≤ 1.5 times normal
  • No active bleeding
  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided disease has remained stable for the past 6 months
  • No unstable angina or myocardial infarction within the past 6 months
  • No neuropathy (sensory and motor) > CTCAE grade 1
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
  • No septicemia, severe infection, or acute hepatitis
  • No other invasive malignancy within the past 5 years except non-melanoma skin cancer or localized breast cancer
  • No circumstance that would preclude study participation
  • No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies (applies to part C only)
  • No clinically significant proteinuria

    • Must have urine protein-creatinine ratio (UPCR) < 1
  • No serious, non-healing wound, ulcer, or bone fracture (applies to part C only)
  • At least 3-6 months since prior abdominal fistula or gastrointestinal perforation and fully recovered (part C only)
  • No history of intra-abdominal abscess within the past 28 days (applies to part C only)
  • No active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels (applies to part C only)
  • No history or evidence (upon physical examination) of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases (applies to part C only)
  • No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study (applies to part C only)
  • No significant traumatic injury within 28 days (applies to part C only)
  • No clinically significant cardiovascular disease, including any of the following (applies to part C only):

    • Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction or unstable angina < 6 months prior to registration
    • New York Heart Association (NYHA) Grade II or greater congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • CTCAE Grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
    • History of CVA within the past six months
  • No clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition (applies to part C only)
  • No prior therapy with any anti-VEGF drug, including bevacizumab (applies to part C only)
  • No prior chemotherapy

    • Prior adjuvant chemotherapy for localized breast cancer allowed provided the therapy was completed at least 3 years before registration to study and the patient remains free of recurrent or metastatic disease
  • No prior radiotherapy
  • No prior cancer therapy that would contraindicate study treatment
  • No anticipation of invasive procedures, including any of the following (applies to part C only):

    • Major surgical procedure or open biopsy within 28 days prior to the first date of bevacizumab therapy (cycle 2)
    • Major surgical procedure anticipated during the course of the study
    • Core biopsy within 7 days prior to the first date of bevacizumab therapy
  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: NCT00085358

Locations
United States, California
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
United States, Colorado
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States, 80010
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, Ohio
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates-Yale
Tulsa, Oklahoma, United States, 74136-1929
Cancer Care Associates-Midtown
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Investigators
Principal Investigator: Joan Walker Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085358     History of Changes
Other Study ID Numbers: NCI-2009-00619, GOG-9916, U10CA027469
Study First Received: June 10, 2004
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Carcinoma
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Cystadenocarcinoma
Cystadenocarcinoma, Serous
Cystadenocarcinoma, Mucinous
Carcinosarcoma
Mixed Tumor, Mullerian
Carcinoma, Endometrioid
Brenner Tumor
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms, Cystic, Mucinous, and Serous

ClinicalTrials.gov processed this record on October 16, 2014