Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer

NCT00023660 | Completed Phase 1 DMC

• 2 other identifiers: RTOG-C-0128CDR0000068849
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 36

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways and combining it with chemotherapy may kill more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib, fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.

Conditions

Cervical Cancer

Keywords

stage III cervical cancer; stage IB cervical cancer; stage IIB cervical cancer; stage IIA cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous cell carcinoma

Interventions

celecoxib DRUG

cisplatin DRUG

fluorouracil DRUG

brachytherapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the cervix * Stage IIB-IVA OR * Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm * No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease * No metastatic disease outside of pelvis * No para-aortic disease PATIENT CHARACTERISTICS: Age: * 18 to 85 Performance status: * Zubrod 0-2 Life expectancy: * At least 6 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST or ALT no greater than 2.5 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 50 mL/min * Calcium no greater than 1.3 times ULN Cardiovascular: * No severe heart disease Other: * Not pregnant or nursing * Negative pregnancy test * HIV negative * No prior allergy to sulfonamides or non-steroidal anti-inflammatory drugs (NSAIDs) * No prior hypersensitivity to celecoxib or any component of its formulation * No medical or psychiatric illness that would preclude study * No active gastrointestinal (GI) ulcer, GI bleeding, or inflammatory bowel disease * No other prior malignancy within the past 5 years except cutaneous basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding Surgery: * No prior surgery for cervical cancer except biopsy Other: * No concurrent phenytoin or lithium * No other concurrent NSAIDs

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

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (36)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Mills-Peninsula Health Services

Burlingame, California, 94010, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0128, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33256-2110, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

Ball Memorial Hospital Cancer Center

Muncie, Indiana, 47303-3499, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

South Jersey Regional Cancer Center

Millville, New Jersey, 08332, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

Mount Holly, New Jersey, 08060, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Akron City Hospital - Summa Health System

Akron, Ohio, 44304, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Mercy Fitzgerald Hospital

Darby, Pennsylvania, 19023, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5097, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (6)

• Viswanathan AN, Moughan J, Small W Jr, Levenback C, Iyer R, Hymes S, Dicker AP, Miller B, Erickson B, Gaffney DK. The quality of cervical cancer brachytherapy implantation and the impact on local recurrence and disease-free survival in radiation therapy oncology group prospective trials 0116 and 0128. Int J Gynecol Cancer. 2012 Jan;22(1):123-31. doi: 10.1097/IGC.0b013e31823ae3c9.

  PMID: 22193645 BACKGROUND

• Weidhaas JB, Li SX, Winter K, Ryu J, Jhingran A, Miller B, Dicker AP, Gaffney D. Changes in gene expression predicting local control in cervical cancer: results from Radiation Therapy Oncology Group 0128. Clin Cancer Res. 2009 Jun 15;15(12):4199-206. doi: 10.1158/1078-0432.CCR-08-2257. Epub 2009 Jun 9.

  PMID: 19509178 RESULT

• Zempolich K, Fuhrman C, Milash B, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Gaffney DK. Changes in gene expression induced by chemoradiation in advanced cervical carcinoma: a microarray study of RTOG C-0128. Gynecol Oncol. 2008 May;109(2):275-9. doi: 10.1016/j.ygyno.2008.01.027. Epub 2008 Mar 4.

  PMID: 18299147 RESULT

• Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Greven K. A Phase II study of acute toxicity for Celebrex (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: primary endpoint analysis of RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):104-9. doi: 10.1016/j.ijrobp.2006.08.002. Epub 2006 Nov 2.

  PMID: 17084549 RESULT

• Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Small W, Greven K. Efficacy and patterns of failure for locally advanced cancer of the cervix treated with celebrex (celecoxib) and chemoradiotherapy in RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):111-7. doi: 10.1016/j.ijrobp.2007.02.050. Epub 2007 May 4.

  PMID: 17482376 RESULT

• Gaffney DK, Winter K, Fuhrman C, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Zempolich K. Feasibility of RNA collection for micro-array gene expression analysis in the treatment of cervical carcinoma: a scientific correlate of RTOG C-0128. Gynecol Oncol. 2005 May;97(2):607-11. doi: 10.1016/j.ygyno.2005.01.014.

  PMID: 15863167 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Celecoxib; Cisplatin; Fluorouracil; Brachytherapy; 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)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Therapeutics

Study Officials

• David K. Gaffney, MD, PhD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: January 1, 2005
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

US (36)