Docetaxel and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer

NCT00452920 | Withdrawn Phase 1 DMC

• 3 other identifiers: 20020358SCCC-2002058WIRB-20050719
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients with stage II, stage III, or stage IV cervical cancer.

Conditions

Cervical Cancer

Keywords

cervical squamous cell carcinoma; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose (Phase I)

• Progression-free survival (Phase II)

Secondary Outcomes (2)

• Response (Phase II)

• Toxicity (Phase II)

Interventions

docetaxel DRUG

cesium Cs 137 RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma of the uterine cervix * Locally advanced (stage IIB- IVA) disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * WBC ≥ 3,000/mm\^3 * Creatinine normal * Bilirubin normal * SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) ≤ ULN OR AP ≤ 4 times ULN if SGOT and SGPT ≤ ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment * No history of severe allergic reactions to agents containing polysorbate 80 * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would preclude compliance with study requirements * No peripheral neuropathy ≥ grade 2 * No HIV positivity PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior unrelated therapy and recovered * No prior chemotherapy or pelvic radiotherapy * No other concurrent investigational agents or anticancer agents or therapies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Docetaxel; Cesium-137; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; 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; Therapeutics

Study Officials

• Joseph A. Lucci, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: September 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)