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

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Collaborators: Chang Gung Memorial Hospital; China Medical University Hospital; Chung Shan Medical University; Kaohsiung Medical University Chung-Ho Memorial Hospital; Kaohsiung Veterans General Hospital.; National Cheng-Kung University Hospital; Taiwan Ministry of Science and Technology
• Treatments: Letrozole; Tamoxifen

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