Cisplatin for Metastatic Anal Canal Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Anal Canal Carcinoma+9 More
Cisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two different chemotherapy drug combinations to see which one is more effective in treating anal cancer.

Eligible Conditions
  • Metastatic Anal Canal Carcinoma
  • Anal Basaloid Carcinoma
  • Anal canal
  • Carcinoma of anal canal
  • Stage IV Anal Canal Cancer
  • Malignant Neoplasms
  • Squamous Cell Anal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Up to 3 years

Week 12
DCR defined as CR, PR, or stable disease (SD) assessed according to RECIST criteria v1.1
Week 24
DCR defined as CR, PR, or SD assessed according to RECIST criteria v1.1
Year 3
Changes in QOL
Month 12
PFS
Month 12
OS
Up to 3 years
Anti-tumor activity and magnitude of response
Best ORR defined as the percentage of patients achieving confirmed partial (PR) or complete responses (CR) as per RECIST v1.1
Best ORR of non-irradiated lesions defined as the percentage of patients achieving confirmed PR or CR as per RECIST v1.1 of non-irradiated sites of disease
Biomarkers, Tumor
Proportion of patients experiencing grade 3-5 toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Sensitivity analysis of ORR
Up to 36 months
Feasibility in terms of proportion of centers that successfully recruit at least one patient
Feasibility in terms of recruitment rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm A (cisplatin, fluorouracil or capecitabine)
1 of 2
Arm B (paclitaxel, carboplatin)
1 of 2

Experimental Treatment

91 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 2

Arm A (cisplatin, fluorouracil or capecitabine)Experimental Group · 5 Interventions: Cisplatin, Capecitabine, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Fluorouracil · Intervention Types: Drug, Drug, Other, Other, Drug
Arm B (paclitaxel, carboplatin)Experimental Group · 4 Interventions: Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Carboplatin · Intervention Types: Other, Drug, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved
Capecitabine
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved
Fluorouracil
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
103 Previous Clinical Trials
171,944 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,836 Total Patients Enrolled
1 Trials studying Metastatic Anal Canal Carcinoma
137 Patients Enrolled for Metastatic Anal Canal Carcinoma
Cathy EngPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
352 Total Patients Enrolled
1 Trials studying Metastatic Anal Canal Carcinoma
137 Patients Enrolled for Metastatic Anal Canal Carcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Previous definitive chemo-radiation is permitted for early stage tumors (cisplatin-based chemotherapy [chemo]-radiation is permitted but only if tumor progression/relapse occurs after 6 months from treatment completion).
Measurable disease according to RECIST criteria.
Hemoglobin (Hb) > 9 g/dl for males and > 8 g/dl for females.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.