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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005840
First Posted: January 27, 2003
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]

Secondary Outcome Measures:
  • Number of dose level combinations that will have been evaluated prior to MTD establishment [ Time Frame: Up to 60 months ]
  • Site (local/distant) of treatment failure [ Time Frame: Up to 5 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000067856
GOG-9907 ( Other Identifier: Gynecologic Oncology Group )
GOG-9907 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: June 2, 2000
First Posted: January 27, 2003
Last Update Posted: December 31, 2014
Last Verified: December 2014

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