Cervical Cancer Clinical Trial
Official title:
A Phase I Study Of Tirapazamine In Combination With Radiation And Weekly Cisplatin In Patients With Locally Advanced Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as tirapazamine and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Tirapazamine may help cisplatin kill more tumor cells by making tumor cells more
sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells.
Tirapazamine may also make tumor cells more sensitive to radiation therapy. Giving radiation
therapy in different ways together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of tirapazamine when
given together with cisplatin and radiation therapy in treating patients with stage IB,
stage II, stage III, or stage IVA cervical cancer.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and the recommended phase II and III dose of
tirapazamine when combined with cisplatin and radiotherapy in patients with Stage
IB-IVA squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the
cervix.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine failure-free survival of patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine time to locoregional failure in patients treated with this regimen.
- Determine patterns of failure for the site of first failure in patients treated with
this regimen.
- Determine the 12-week post-treatment complete response rate in patients treated with
this regimen.
OUTLINE: This is a multicenter, dose-escalation study of tirapazamine.
Patients receive tirapazamine IV over 2 hours on day 1 of weeks 1-5 and on days 3 and 5 of
weeks 1 and 2 (cohort 2 only), OR days 3 and 5 of weeks 1-4 (cohort 3 only). Patients also
receive cisplatin IV over 1 hour on day 1 of weeks 1-6. Patients concurrently undergo
external beam radiotherapy once daily on days 1-5 for 5-5.5 weeks. After completion of
chemoradiotherapy, patients undergo low-dose brachytherapy (up to 2 implants within an
8-week period) OR high-dose brachytherapy twice weekly for 5 treatments. Treatment continues
in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the
MTD.
Patients are followed at 2, 4, and 8 weeks, at 3 and 6 months, every 3 months for 2 years,
and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 3-22 patients will be accrued for this study.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT03367871 -
Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
| Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT04806945 -
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04185389 -
Long-Term Follow-Up of HPV FOCAL Participants
|
||
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT05120167 -
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
|
N/A | |
| Recruiting |
NCT05483491 -
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
| Completed |
NCT05862844 -
Promise Women Project
|
N/A | |
| Recruiting |
NCT04934982 -
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)
|
N/A | |
| Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
| Terminated |
NCT04864782 -
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A |