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

NCT00258362 | Completed Phase 2 Results DMC

• 3 other identifiers: 2004LS021UMN-WCC-3813062
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometrial Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Estimated to be Progression-Free and Alive

  This estimate was determined by using a statistical method of analysis (Kaplan-Meier).

  1 Year, 2 Years, 3 Years

Secondary Outcomes (1)

• Percent of Patients Estimated to be Alive

  1 Year, 2 Years, 3 Years

Study Arms (1)

Patients with Endometrial Cancer

EXPERIMENTAL

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).

Drug: carboplatin; Drug: docetaxel; Radiation: radiation therapy

Interventions

carboplatin DRUG

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

Also known as: Gemzar(R)

Patients with Endometrial Cancer

docetaxel DRUG

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

Also known as: Taxotere(R)

Patients with Endometrial Cancer

radiation therapy RADIATION

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

Also known as: radiation

Patients with Endometrial Cancer

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• Sanofi: collaborator

Study Sites (2)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin; Docetaxel; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; 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)

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

Results Point of Contact

• Title: Melissa Geller, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

gelle005@umn.edu

612-626-3111

Study Officials

• Melissa A. Geller, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: November 22, 2005
• First Posted: November 24, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 28, 2017
• Results First Posted: November 11, 2010

Record last verified: 2017-12

Locations

US (2)