Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer

NCT ID: NCT00258362

Last Updated: 2017-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel.

Secondary

• Determine the toxic effects of this regimen in these patients.
• Determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin.

After completion of study treatment, patients are followed periodically for 2 years.

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Endometrial Cancer

Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m\^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.

docetaxel

Intervention Type: DRUG

75 mg/m\^2 on Day 1 of each course

radiation therapy

Intervention Type: RADIATION

Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)

Interventions

carboplatin

Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.

Intervention Type: DRUG

docetaxel

75 mg/m\^2 on Day 1 of each course

Intervention Type: DRUG

radiation therapy

Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)

Intervention Type: RADIATION

Other Intervention Names

Gemzar(R); Taxotere(R); radiation

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed endometrial cancer
• Advanced or recurrent disease

• Stage IIIB or IIIC disease

• Stage IIIA disease allowed provided there is serosal involvement or direct extension or metastasis to the adnexa
• No stage IIIA confirmed by only positive peritoneal washings
• Stage IVA or IVB disease
• Failed local therapy or considered incurable with local therapy
• Measurable or evaluable disease

• Not required for newly diagnosed stage III or IV disease with no remaining disease after surgery
• Performance status Gynecology Oncology Group (GOG) 0-1
• Life expectancy at least 12 weeks
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• Meets 1 of the following criteria:

• Alkaline phosphatase (AP) normal AND aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
• AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
• AP ≤ 5 times ULN AND AST or ALT normal
• Bilirubin normal
• No acute hepatitis
• Creatinine ≤ 1.5 mg/dL

Exclusion Criteria

• Known hypersensitivity to docetaxel or polysorbate 80
• Severe infection
• Septicemia
• Pregnant or nursing
• Positive pregnancy test
• Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment
• Peripheral neuropathy ≥ grade 2
• Severe gastrointestinal bleeding requiring a blood transfusion or hospitalization
• Other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix
• Prior chemotherapy
• Prior radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa A. Geller, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Countries

United States

Other Identifiers

UMN-WCC-38

Identifier Type: OTHER

Identifier Source: secondary_id

13062

Identifier Type: OTHER

Identifier Source: secondary_id

2004LS021

Identifier Type: -

Identifier Source: org_study_id