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

Endometrial Serous Adenocarcinoma Clinical Trial

Official title:

Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005840
• Other study ID #: GOG-9907
• Secondary ID: NCI-2012-02334CD
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2000
• Last updated: December 29, 2014
• Start date: July 2000

Study information

• Verified date: December 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Stage III Uterine Corpus Cancer
• Stage IV Uterine Corpus Cancer
• Uterine Neoplasms

Intervention

Drug:
• Paclitaxel
Given IV
• Cisplatin
Given IV

Radiation:
• Radiation Therapy
Undergo whole abdominal radiation therapy

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0	Calculated using a 90% conditional likelihood-based confidence bound.	Up to 30 days post-radiotherapy	Yes
Primary	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		Up to 6 months post-radiotherapy	Yes
Secondary	Number of dose level combinations that will have been evaluated prior to MTD establishment		Up to 60 months	No
Secondary	Site (local/distant) of treatment failure		Up to 5 years	No