A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus

NCT00584909 | Terminated Phase 2 Results DMC

• 2 other identifiers: F060328016 (UAB 0604)UAB 0604
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study us to determine the best treatment for patients with endometrial cancer who are at an elevated risk for recurrence.

Conditions

Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  Number of months of survival with no evidence of disease

  4 years - Median follow up time of 45.3 months

Secondary Outcomes (1)

• Toxicity

  4 years

Study Arms (1)

Open Label

EXPERIMENTAL

Drug: Paclitaxel and carboplatin combination

Interventions

Paclitaxel and carboplatin combination DRUG

Paclitaxel will be administered at an appropriate dose (175 mg/m2) as a 3-hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing the Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate (GFR).

Open Label

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 a elevated risk, surgical stage II, stage IC, grade 2 or 3 adenocarcinoma of the endometrium.
• Patients must have undergone, a total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and a pelvic and para-aortic lymphadenectomy.
• Patients must have adequate organ function defined as:
• Platelets \>/= 100,000/µ
• Granulocytes (ANC)\>/= 1,500/µl
• Creatinine\</= 1.6 mg/dl
• SGOT (AST) \</= 3x upper limits of normal
• Bilirubin within institutional normal limits
• Patients must have adequate performance status (ECOG performance status 0-2 or Karnofsky Performance Status \>40)
• Patients must be age 19 or greater and have signed informed consent.

You may not qualify if:

• Patients with history of other malignancies within 5 years (except non- melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible.
• Patients with high-risk histologic subtypes of endometrial cancer such as papillary serous or clear cell histology are ineligible.
• Patients with histologic evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible.
• Patients who have received past pelvic radiotherapy are ineligible.
• Patients receiving any other investigational agents are ineligible.
• Patients with known hypersensitivity to paclitaxel and/or carboplatin are ineligible.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Women's and Infant Center, 1700 6th Avenue South

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Paclitaxel

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

This study was terminated early due to slow accrual. 4 patients withdrew from the study due to side-effects from the treatment. All 9 patients were evaluable for toxicity and PFS.

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

  Assistant Professor, Dept of OB/Gyn, Division of GYN Oncology

  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: March 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: January 27, 2017
• Results First Posted: March 29, 2012

Record last verified: 2017-01

Locations

US (1)