Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed 18 to 85 NCI RTOG-C-0128 NCT00023660

Objectives

1. Determine treatment-related toxicity rates in patients with locally advanced cervical cancer treated with external beam radiotherapy and brachytherapy concurrently with celecoxib, fluorouracil, and cisplatin.
2. Determine whether this regimen increases locoregional control rates, distant control, disease-free survival, and overall survival in these patients.
3. Determine whether first-failure patterns in patients treated with this regimen are changed compared to historical controls.

Entry Criteria

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

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

Patient Characteristics:

Age:

• 18 to 85

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 6 months

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 83 patients will be accrued for this study within 1.5 years.

Outline

This is a multicenter study.

Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy. Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Zempolich K, Fuhrman C, Milash B, et al.: Changes in gene expression induced by chemoradiation in advanced cervical carcinoma: a microarray study of RTOG C-0128. Gynecol Oncol 109 (2): 275-9, 2008.[PUBMED Abstract]

Gaffney DK, Winter K, Dicker AP, et al.: 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 67 (1): 104-9, 2007.[PUBMED Abstract]

Gaffney DK, Winter K, Dicker AP, et al.: 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 69 (1): 111-7, 2007.[PUBMED Abstract]

Gaffney DK, Winter K, Dicker AP, et al.: Celebrex™ (celecoxib) and chemoradiation in patients with locally advanced cervical cancer. an efficacy report of RTOG 0128. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-70, S41, 2006.

Gaffney DK, Winter K, Dicker A, et al.: A phase I-II study of COX-2 inhibitor, celebrex (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: primary endpoint analysis of RTOG 0128. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-155, S93, 2005.

Gaffney DK, Winter K, Fuhrman C, et al.: 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 97 (2): 607-11, 2005.[PUBMED Abstract]

Zempolich K, Milash B, Fuhrman C, et al.: Changes in gene expression induced by chemoradiation in advanced cervical carcinoma: a microarray study of RTOG C-0128. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-159, S96, 2005.

Gaffney DK, Winter K, Fuhrman C, et al.: Feasibility of RNA collection for micro-array gene expression analysis in the treatment of cervical carcinoma: a scientific correlate of RTOG C-0128. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-2239, S479, 2004.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

David Gaffney, MD, PhD, Protocol chair		Ph: 801-581-2396; 877-585-0303

Registry Information
Official Title		A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer
Trial Start Date		2001-08-24
Registered in ClinicalTrials.gov		NCT00023660
Date Submitted to PDQ		2001-07-05
Information Last Verified		2003-10-17
NCI Grant/Contract Number		CA21661

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