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A Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix (TGOG1005)

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ClinicalTrials.gov Identifier: NCT02482740
Recruitment Status : Unknown
Verified June 2015 by Tang Yuan Chu, Buddhist Tzu Chi General Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
Sponsor:
Collaborators:
Chang Gung Memorial Hospital
Chung Shan Medical University
China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
Taiwan Ministry of Science and Technology
Information provided by (Responsible Party):
Tang Yuan Chu, Buddhist Tzu Chi General Hospital

Brief Summary:
The investigators design a phase 2, open labeled, randomized trial of Tamoxifen (20 mg/day) and Letrozole (2.5 mg) in treatment of squamous carcinoma of the cervix. Forty four patients with recurrent or persistent disease will be recruited, randomized, treated and followed three-monthly for 12 months. The primary end point is the treatment response rates. Secondary end points include survivals, ECOG performance status, quality of life and efficacy of biomarkers in predicting the responses. Candidate biomarkers including ER, PR, GPER and HPV genotype in paraffin cancer tissues as well as methylated genes in the blood will be studied in relation to the therapeutic outcomes.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Drug: Letrozole Drug: tamoxifen Phase 2

Detailed Description:

Although human papillomavirus (HPV) is a necessary cause of cervical cancer, HPV infection itself is inefficient and insufficient to cause cancer. New evidences have suggested endogenous and exogenous sex hormones confer risk of developing cervical cancer. In unscreened populations, incidence of cervical cancer starts after menarche and constantly increases before menopause, after then the incidence is flattening and declines [21]. Indeed, after menopause, newly incident CIN3 is seldom detected[22]. Large-scale epidemiological studies also showed high number of full-term pregnancy[23] (rather than abortion) and long-term use of hormonal contraceptives[24] to be independent risk factors of cervical cancer. These evidences pointed to female sex hormones to be another culprit of cervical cancer.

The role of estrogen and ERα on HPV-induced cervical carcinogenesis is best demonstrated by the pK14-HPV E6/E7transgenic mice which, without estrogen exposure, develop benign skin tumors only. However, when these mice are treated with exogenous estradiol at physiological level, they develop cervical cancers in nearly 100% efficiency[25-28]. These cervical neoplasia recapitulate characteristics of human cervical cancer in all aspects: originated from the squamous-columnar junction, with early lesions of atypical squamous metaplasia, CIN and to invasive squamous cell carcinoma [29]. Most importantly, removal of exogenous estrogen or castration of these mice led to diminish of progression and partial regression of pre-existing neoplasia[30].

The investigators design an open, randomized, multi-center trial of tamoxifen and letrozole in treatment of recurrent or persistent squamous cell carcinoma of the cervix. Patients with recurrent or persistent SCC of cervix who are not amenable for further cytotoxic treatment will be randomized by block and by participating center to one of the two arms. The block size will be two . Medication will be given orally in daily dose of tamoxifen (Nolvadex) 20 mg, letrozole (Femara) 2.5 mg until disease progression or until the end of the study.

Primary end point of the study is the response rate (complete response and partial response rates) for tamoxifen and letrozole arms. Secondary end points include progression-free survival (PFS) and overall survival (OS) compared to the historical results, ECOG Performance Status, quality of life and outcome predictors (biomarkers and clinical characteristics) of responsiveness and survival. The experienced survival data of the participating center will be compared.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Randomized, Multi-center, Phase 2 Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix: the Efficacy and New Biomarkers
Study Start Date : May 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: tamoxifen
tamoxifen 20 mg given everyday for 12 months
Drug: tamoxifen
tamoxifen was given 20 mg qd for 12 months or till disease progress
Other Name: Nolvadex

Active Comparator: letrozole
letrozole 2.5 mg given everyday for 12 months
Drug: Letrozole
letrozole 2.5 mg qd was given for 12 months or till disease progress
Other Name: Femara




Primary Outcome Measures :
  1. The response rate [ Time Frame: one year ]
    The guideline for the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) will be followed. Target tumor will be identified and followed by CT scan. Other efficacy parameters are tumor markers (SCC), and pelvic examination and physical examination findings.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: one year ]
    Progression-free survival (PFS) comparing to the historical results

  2. Quality of life [ Time Frame: one year ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24 and C30 will be evaluated for every patient at every visit during study period.

  3. ECOG Performance Status [ Time Frame: one year ]
    ECOG Performance status will be evaluated every visit during study period

  4. Overall survival [ Time Frame: one year ]
    overall survival (OS) comparing to the historical results



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. With a histology proven primary squamous cell carcinoma of the cervix prior to the treatment failure
  2. Must sign and date informed consent.
  3. With age between 30 and 85
  4. With tissue blocks of the recurrent cancer lesion or primary cancer lesion available for the study.
  5. With a treatment-free interval of at least 4 weeks.
  6. With currently (within 1 month) measurable (by CT) tumor of at least 2 cm in one diameter (at least twice the scan slice thickness), AND elevated SCC level over 2 folds of the institutional upper limit of normal (ULN),
  7. With a ECOG performance status score of 0 to 2,
  8. With adequate hematologic function (ANC≧500/uL and platelets≧50,000/uL),
  9. With adequate renal function (serum creatinine≦2.0 mg/dL; if higher, then creatinine clearance≧40 mL/min was required),
  10. With adequate hepatic function (ALT/AST ≦3.0 folds of ULN

Exclusion Criteria:

  1. With histology type other than SCC
  2. Had liver, brain metastasis or malignant ascites
  3. Those having multiple metastasis (more than one metastasis lesion)
  4. Whose cancer had been treated for more than three therapeutic courses [including 1 primary therapy (Operation+ CCRT is considered 1 primary therapy) and 2 secondary therapies] courses.
  5. Who have received any investigational drugs within 30 days prior to enrollment
  6. Who were pregnant or lactating
  7. Who are taking selective serotonin receptor inhibitors (SSRI) (eg. Prozac, Celexa, Lexapro, Lubox, Paxi, Zoloft, etc.)
  8. With pulmonary embolism or other veneous embolism
  9. With uncontrolled medical conditions such as cardiac disease, cirrhosis of liver, active on chronic hepatitis, diabetes mellitus, autoimmune disease.
  10. With current or prior therapy (less than 3 months ) of selective estrogen receptor modulators (SERMs) (tamoxifen, raloxifen, fulvestrant, etc.), or aromatase inhibitors (eg. Letrozole, Anastrozole, Exemestane, Vorozole, Formestane, Fadrozole, etc.)
  11. Currently taking Warfarin or Rivaroxaben .
  12. With history of malignant disease, except those had been disease-free for at least 5 years.
  13. Patient who had allergy history to Tamoxifen or Letrozole

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482740


Contacts
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Contact: Mun Kun Hong, MD +886-3-8561825 ext 2224 jeff06038@gmail.com
Contact: Tang Yuan Chu, PhD +886-3-8561825 ext 5610 hidrchu@gmail.com

Locations
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Taiwan
Dept. of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital Not yet recruiting
Kaohsiung, No 123, Dapi Rd, Niaosong Dist, Taiwan, 83301
Contact: Chan-Chao Chang, Bachelor    +886975056401    chanchao@adm.cgmh.org.tw   
Contact: Hung-Chung Fu    +886975056423    allen133@adm.cgmh.org.tw   
Sub-Investigator: Hao Lin, Bachelor         
Sub-Investigator: Yu-Che Ou, Bachelor         
Sub-Investigator: Ching-Chou Tsai, Master         
Sub-Investigator: Chen-Hsuan Wu, Bachelor         
Kaohsiung Medical University Chung-Ho Memorial Hospital Not yet recruiting
Kaohsiung, No.100, Ziyou 1st Rd., Sanmin Dist., Taiwan, 807-56
Contact: Yu-Chieh Chen, Master    +886975356642    benjamin2727@yahoo.com.tw   
Contact: Yu-Chieh Chen, Master    +886975-356-642    benjamin2727@yahoo.com.tw   
Chung Shan Medical University Hospital Not yet recruiting
Taichung, No.110,sec. 1,Jianguo NRd.,South Dist., Taiwan, 40201
Contact: Chih-Jen Tseng, Master    +8864-24739595 ext 34501    tsengcj@gmail.com   
National Cheng Kung University Hospital Not yet recruiting
Tainan, No.138, Shengli Rd., North Dist., Taiwan, 70403
Contact: Ching-I Wu, Bachelor         
Contact: Ya-Min Cheng    +886921566219    chengym@mail.ncku.edu.tw   
China Medical University Hospital Not yet recruiting
Taichung, No.2, Yude Rd., North Dist.,, Taiwan, 40447
Contact: Wu-Chou Lin, PhD    +886-4-22052121 ext 2063    sun.bau@msa.hinet.net   
Contact: Lian-Shung Yeh, Master    +886-4-22052121 ext 2063    lsyeh@mail.cmuh.org.tw   
Sub-Investigator: Yao-Ching Hung, PhD         
Kaohsiung Veterans General Hospital Not yet recruiting
Kaohsiung, No.386, Dazhong 1st Rd., Zuoying Dist., Taiwan, 81362
Contact: Wen-Shiung Liou, MD    +88673422121 ext 8191    wsliou@vghks.gov.tw   
Contact: Wen-Shiung Liou, MD    +886975581667    wsliou@vghks.gov.tw   
Department of OB/GYN, Linkou Chang Geng Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chyong-Huey Lai, .MD    +886975365883    jean0311@hotmail.com   
Contact: Huei-Jean Huang, MD    +886975366298    hjhuang@cgmh.org.tw   
Sub-Investigator: Ting-Chang Chang, MD         
Sub-Investigator: Kuan-Gen Huang, MD         
Sub-Investigator: Angel Chao, PhD         
Sub-Investigator: Cheng-Tao Lin, MD         
Sub-Investigator: Jian-Tai Qiu, MD         
Sub-Investigator: Min-Yu Chen, MD         
Sub-Investigator: Yunhsin Tang, MD         
Sub-Investigator: Hung-Hsueh Chou, MD         
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Chang Gung Memorial Hospital
Chung Shan Medical University
China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
Taiwan Ministry of Science and Technology
Investigators
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Principal Investigator: Tang Yuan Chu, PhD Department of Obstetrics and Gynecology, Buddhist Tzu Chi General Hospital, 707, Section 3, Chung Yang Road, Hualien 970, Taiwan (R.O.C.)

Publications:

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Responsible Party: Tang Yuan Chu, The Chief of Department of Obstetrics and Gynecology, Buddhist Tzu Chi General Hospital, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT02482740     History of Changes
Other Study ID Numbers: TGOG1005
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by Tang Yuan Chu, Buddhist Tzu Chi General Hospital:
Uterine Cervical Neoplasms
antiestrogens
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Tamoxifen
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents