Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dennis Yi-Shin Kuo, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01041027
First received: December 29, 2009
Last updated: January 11, 2016
Last verified: January 2016

December 29, 2009
January 11, 2016
September 2008
January 2017   (final data collection date for primary outcome measure)
Progression-free survival (PFS) [ Time Frame: From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves.
  • To assess and document location of disease recurrence (distant vs. local. vs. both) using this treatment regimen. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate the toxicity of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with high-risk endometrial cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01041027 on ClinicalTrials.gov Archive Site
  • Expression levels of IGF-1 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of IGF-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
  • Expression levels of IGF-2 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of IGF-2 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
  • Expression levels of IGFBP-1 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of IGFBP-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
  • Expression levels of IGFBP-3 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of IGFBP-3 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
  • Expression levels of insulin receptor [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of insulin receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
  • Expression levels of IGF-1 receptor [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of IGF-1 receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
  • Expression levels of estrogen receptor [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of estrogen receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
  • Expression levels of progesterone receptor [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associations of PFS with tumor tissue expression levels of progesterone receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
To evaluate the associations of cancer recurrence with tumor tissue expression levels. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer
A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging
This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Giving radiation therapy with chemotherapy may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To evaluate progression-free survival. II. To assess and document location of disease recurrence (distant vs local vs both) using this treatment regimen.

II. To evaluate the toxicity of radiation therapy "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with high-risk endometrial cancer.

III. To evaluate the associations of cancer recurrence with tumor tissue expression levels of insulin-like growth factor-I (IGF-I), IGF-II, insulin-like growth factor binding protein 1 (IGFBP-1) and -3, insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.

RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo high dose rate (HDR) brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Endometrial Adenocarcinoma
  • Stage IA Uterine Corpus Cancer
  • Stage IB Uterine Corpus Cancer
  • Stage II Uterine Corpus Cancer
  • Stage IIIA Uterine Corpus Cancer
  • Stage IIIB Uterine Corpus Cancer
  • Stage IIIC Uterine Corpus Cancer
  • Stage IVA Uterine Corpus Cancer
  • Stage IVB Uterine Corpus Cancer
  • Drug: Paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • TAX
  • Drug: Carboplatin
    Given IV
  • Radiation: Internal Radiation Therapy
    Undergo HDR brachytherapy
    Other Names:
    • Brachytherapy
    • Internal Radiation
    • Internal Radiation Brachytherapy
    • Radiation Brachytherapy
  • Radiation: External Beam Radiation Therapy
    Undergo EBRT
    Other Names:
    • Definitive Radiation Therapy
    • EBRT
    • External Beam RT
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Experimental: Treatment (paclitaxel, carboplatin, radiation therapy)

CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.

RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.

Interventions:
  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Radiation: Internal Radiation Therapy
  • Radiation: External Beam Radiation Therapy
  • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
Not Provided
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:

    • Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement;
    • Surgical stage I disease with >= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3);
    • Any surgical stage II disease (II);
    • Any surgical stage III disease (IIIA, IIIB, IIIC); and
    • Any surgical stage IV disease with no residual macroscopic tumor
  • Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of < 2
  • Written voluntary informed consent

Exclusion Criteria:

  • Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional upper limit of normal
  • Total serum bilirubin > 1.5 mg/dl
  • History of chronic or active hepatitis
  • Serum creatinine > 2.0 mg/dl
  • Platelets < 100,000/mm^3
  • Absolute neutrophil count (ANC) < 1500/mm^3
  • Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)
  • Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
  • Patient with any prior chemotherapy or radiotherapy for pelvic malignancy
  • Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
  • Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
Female
18 Years and older
No
United States
 
NCT01041027
08-03-060, NCI-2013-01224, 07-062, NCI-2012-00458, 08-03-060, P30CA013330
Yes
Not Provided
Not Provided
Dennis Yi-Shin Kuo, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Principal Investigator: Dennis Kuo Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP