Description:
Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and
mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these
are largely done before the wide use of premedication (steroid and vitamin B12) for
pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a
commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.
This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in
patients with recurrent or metastatic breast cancer previously treated with or resistant to
an anthracycline and taxane.
Title
- Brief Title: PemVin vs Vin in Previously Treated Metastatic Breast Cancer
- Official Title: Randomized Phase II Trial of Pemetrexed Plus Vinorelbine Versus Vinorelbine in Patients With Recurrent or Metastatic Breast Cancer Previously Treated With or Resistant to Anthracycline and Taxane
Clinical Trial IDs
- ORG STUDY ID:
H1607-172-780
- NCT ID:
NCT03242616
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Pemetrexed + Vinorelbine | | Pemetrexed + Vinorelbine |
| Vinorelbine | | Vinorelbine |
Purpose
Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and
mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these
are largely done before the wide use of premedication (steroid and vitamin B12) for
pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a
commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.
This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in
patients with recurrent or metastatic breast cancer previously treated with or resistant to
an anthracycline and taxane.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Pemetrexed + Vinorelbine | Experimental | Vinorelbine (25 mg/m2, day 1 & 8)
Pemetrexed (500 mg/m2, day 1)
Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th…. cycle after then.)
Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose
Dexa 4mg po bid on D0-2 | |
| Vinorelbine | Active Comparator | Vinorelbine (25 mg/m2, day 1 & 8) | |
Eligibility Criteria
Inclusion Criteria:
1. histologically confirmed, recurrent or metastatic breast cancer
2. HER2-negative
3. ECOG PS 0-2
4. Age ≥ 20 years
5. Anthracycline- and Taxane-pretreated
6. Wash-out period of 3 weeks for cytotoxic chemotherapy
7. Wash-out period of 2 weeks for hormone therapy or radiotherapy
8. measurable or non-measurable lesions by RECIST v1.1
9. Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL
10. Adequate liver functions
11. Adequate renal functions : sCr≤1.5mg/dL
12. Subjects willing to follow study protocol
13. Informed consent before study entry
Exclusion Criteria:
1. More than 3 lines of chemotherapy for metastatic breast cancer
2. Pregnant or breastfeeding women
3. Previous exposure to Pemetrexed or Vinorelbine
4. Neuropathy (grade 2 or more)
5. Symptomatic CNS metastasis
6. History of malignant disease within 5 years (except for cured basal cell cancer or
squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer)
7. Hypersensitivity to study medication or related drugs
8. Concomitant vaccination for yellow fever
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | progression free survival |
| Time Frame: | response assessment every 6 weeks, for up to 2 years |
| Safety Issue: | |
| Description: | From date of first dose of study drug till the date of documented progression or death from any cause |
Secondary Outcome Measures
| Measure: | response rate |
| Time Frame: | response assessment every 6 weeks, for up to 2 years |
| Safety Issue: | |
| Description: | Proportion of patients with objective response by RECIST version 1.1 |
| Measure: | duration of response |
| Time Frame: | response assessment every 6 weeks, for up to 2 years |
| Safety Issue: | |
| Description: | Time from documentation of tumor response to disease progression |
| Measure: | overall survival |
| Time Frame: | up to 2 years |
| Safety Issue: | |
| Description: | From date of first dose of study drug till the date of death from any cause |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Seoul National University Hospital |
Last Updated
August 8, 2017
