A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer

NCT00584857 | Completed Phase 2 Results DMC

• 2 other identifiers: F040628007 (UAB 0403)UAB 0403
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to determine the optimal treatment for patients with advanced stage or recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates the effectiveness of the combination of hormonal therapy and chemotherapy. This study also will examine the side-effects associated with these drugs and the quality of life of patients on combination therapy.

Conditions

Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year Overall Survival

  Number of subjects alive at 3 years

  3 years - median followup of 40.4 months

Secondary Outcomes (1)

• Toxicity

  3 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Single

Drug: Paclitaxel ,Carboplatin , Megesterol Acetate

Interventions

Paclitaxel ,Carboplatin , Megesterol Acetate DRUG

Paclitaxel will be administered at an appropriate dose (175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at an anti-tumor dosage of 40 mg. This will be given for a total of 6 cycles over 18 weeks with the Megace continuing for 5 years as long as no evidence of recurrence is present.

Chemotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have biopsy proven endometrioid adenocarcinoma or adenosquamous carcinoma.
• Patients must have evidence of primary FIGO Stage III-IVB or recurrent endometrial cancer.
• Patients with non-measurable disease following complete cytoreduction at the time of initial operative management for Stage III-IVB are eligible.
• Patients with recurrent disease must have disease confirmed by one of the following:
• CT Scan
• MRI
• PET Scan
• Physical Exam
• Patients must have adequate organ function defined as:
• Platelets \>/= 100,000/1
• Granulocytes (ANC) \>/= 1,500/
• Creatinine \</= 1.6mg/dl
• SGOT (AST) \</= 3x upper limits of normal
• Bilirubin within institutional normal limits
• Patients must have adequate performance status (ECOG performance status 0-2.

You may not qualify if:

• Patients with history of other malignancies (except non-melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible.
• Patients with high-risk histologic subtypes of endometrial cancer, namely papillary serous or clear cell histology are ineligible.
• Patients with evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible.
• Patients who are less than 8 weeks after the completion of radiotherapy are ineligible.
• Patients receiving any other investigational agents are ineligible.
• Patients with known hypersensitivity to paclitaxel, carboplatin, or megesterol are ineligible.
• Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Women's and Infant Center, 1700 6th Ave S

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Bevis KS, Kilgore LC, Alvarez RD, Straughn JM Jr, Leath CA 3rd. Combination therapy with paclitaxel, carboplatin and megestrol acetate for the management of advanced stage or recurrent carcinoma of the endometrium: a phase II study. J Reprod Med. 2014 Mar-Apr;59(3-4):113-20.

  PMID: 24724218 RESULT

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: J. Michael Straughn, MD
• Organization: UAB

Michael.straughn@ccc.uab.edu

205-934-4986

Study Officials

• John M. Straughn, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: July 1, 2004
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: January 27, 2017
• Results First Posted: March 29, 2012

Record last verified: 2017-01

Locations

US (1)