A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Irradiation

NCT00285415 | Terminated Phase 2

• 2 other identifiers: EndoRTWIRB PRO NUM: 20050247
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the effectiveness of the combination of the two drugs, docetaxel (Taxotere®) and carboplatin (Paraplatin®) followed by radiation directed at the tumor in treating your endometrial cancer.

Conditions

Advanced Endometrial Adenocarcinoma, Stage III A, B, C

Keywords

Advanced endometrial adenocarcinoma, stage III A, B, C

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) for patients treated with docetaxel and carboplatin as measured by RECIST 1.1

  to estimate the overall response rate (ORR) for women with newly diagnosed stages III-IV or recurrent endometrial carcinoma treated with docetaxel and carboplatin followed by tumor volume directed pelvic plus or minus para-aortic irradiation.

  every 3 months

Secondary Outcomes (3)

• Progressive free survival (PFS) for patients treated with docetaxel and carboplatin as measured by CA125.

  every 3 months for 2 years and then every 6 months for 3 years. Yearly after 5 years.

• To estimate overall survival (OS)

  every 3 months for 2 years then every 6 months for 3 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  5 years

Study Arms (1)

Doc and Car

OTHER

Receiving Doc and Car

Drug: Docetaxel and Carboplatin

Interventions

Docetaxel and Carboplatin DRUG

docetaxel (75 mg/m2) + carboplatin (AUC 6) IV every 3 weeks X 6 cycles

Doc and Car

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with advanced endometrial adenocarcinoma, stage III A, B, C and Stage IV confined to the pelvis, and recurrent disease limited to the pelvis.
• Surgical stage III and limited stage IV disease, including those patients with positive adnexa, tumor invading the serosa, positive and/or para-aortic nodes, pelvic metastases, positive pelvic washings or vaginal involvement.
• Histology must be adenocarcinoma, adenosquamous cell, squamous cell, clear cell or serous papillary carcinoma
• Status post surgical resection, including a hysterectomy and bilateral salpingo-oophorectomy within the past
• weeks (Pelvic lymph node and para-aortic lymph node sampling are optional)
• Patients may be sub-optimally or optimally debulked (disease \< 2 cm). Patients are eligible with measurable disease or evaluable
• disease. All positive para-aortic node patients must be further staged by chest CT scan. If chest CT scan is negative, patients are eligible.
• Patients who have met the pre-entry criteria including following lab findings:
• ANC \> 1500, Platelet count \> 100,000/mm3, Hemoglobin ≥ 8 mg/dl, Creatinine \< 2.0 mg/dl.
• Total Bilirubin must be within normal limits. (WNL)
• AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility
• Patients who have signed an approved informed consent.
• GOG Performance Grade 0, 1, or 2.
• Women ≥ 18 years of age

You may not qualify if:

• Patients with Stage IV or recurrent disease outside of the pelvis.
• Patients who have had prior pelvic or abdominal radiation therapy.
• Patients with concomitant malignancy other than non-melanoma skin cancer.
• Patient with a prior malignancy who have been disease-free for \< 5 years or who received prior chemotherapy or radiation therapy for that malignancy.
• Patients with a history of serious co-morbid illness that would preclude protocol therapy.
• Patients with an estimated survival of less than three months.
• Patients with parenchymal liver metastases.
• Patients who received prior chemotherapy excluding low-dose methotrexate for rheumatologic reasons.
• Histology consistent with uterine sarcomas, carcinosarcoma or leiomyosarcoma.
• Women with baseline peripheral neuropathy Grade ≥ 2.
• Women with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.

Sponsors & Collaborators

• Carilion Clinic: lead
• Sanofi: collaborator

Study Sites (2)

Gynecologic Oncology Research & Development, LLC

Greenville, South Carolina, 29601, United States

Location

Carilion GYN Oncology Associates

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Interventions

Docetaxel; Carboplatin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dennis R Scribner, JR, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: April 1, 2005
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

US (2)