Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00005840
First received: June 2, 2000
Last updated: December 29, 2014
Last verified: December 2014
  Purpose
This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.

Condition Intervention Phase
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage III Uterine Corpus Cancer
Stage IV Uterine Corpus Cancer
Drug: Paclitaxel
Drug: Cisplatin
Radiation: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0 [ Time Frame: Up to 30 days post-radiotherapy ] [ Designated as safety issue: Yes ]
    Calculated using a 90% conditional likelihood-based confidence bound.

  • Chronic toxicity based on the NCI CTC Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme [ Time Frame: Up to 6 months post-radiotherapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of dose level combinations that will have been evaluated prior to MTD establishment [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Site (local/distant) of treatment failure [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2000
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (paclitaxel, cisplatin, abdominal radiotherapy)

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Cisplatin
Given IV
Radiation: Radiation Therapy
Undergo whole abdominal radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT

Detailed Description:

OBJECTIVES:

I. Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.

II. Assess the time to disease progression and overall survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed surgical stage III or IV endometrial cancer
  • Any stage clear or serous papillary endometrial cancer
  • Positive para-aortic lymph nodes allowed
  • Tumor must be surgically reduced to 2 cm or less within 8 weeks of study

    • Must have had hysterectomy and bilateral salpingo-oophorectomy
  • No recurrent disease
  • No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes
  • Performance status - GOG 0-2
  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 3 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer
  • No prior chemotherapy
  • No prior radiotherapy
  • See Disease Characteristics
  • No more than 8 weeks since prior surgery
  • No prior anticancer therapy that would preclude study
  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: NCT00005840

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: D. McMeekin Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00005840     History of Changes
Other Study ID Numbers: GOG-9907  NCI-2012-02334  CDR0000067856  GOG-9907  GOG-9907  U10CA027469 
Study First Received: June 2, 2000
Last Updated: December 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Endometrial Neoplasms
Uterine Neoplasms
Cystadenocarcinoma, Serous
Adenocarcinoma, Clear Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016