NCT02560298

Cisplatin and Fluorouracil Compared With Carboplatin and Paclitaxel in Treating Patients With Inoperable Locally Recurrent or Metastatic Anal Cancer

InterAACT - An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin Plus 5-Fluorouracil Versus Carboplatin Plus Weekly Paclitaxel in Patients With Inoperable Locally Recurrent or Metastatic Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well cisplatin and fluorouracil work compared with carboplatin and paclitaxel in treating patients with anal cancer that cannot be removed by surgery, has come back at or near the same place as the primary tumor, or spread to other places in the body. Drugs used in chemotherapy, such as cisplatin, fluorouracil, carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin and fluorouracil are more effective than carboplatin and paclitaxel in treating anal cancer.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate best overall response rate (ORR). SECONDARY OBJECTIVES: I. Overall survival (OS). II. Progression free survival (PFS). III. Disease control rate (DCR) (stable disease \[SD\] or better) at 12 and 24 weeks. IV. Best ORR of non-irradiated lesions. V. Anti-tumor activity and magnitude of response as captured by waterfall plot analyses. VI. Toxicity. VII. Quality of life (QOL). VIII. Feasibility of conducting a multicenter international study on squamous cell carcinoma of the anus (SCCA) and recruit within a reasonable time frame. TERTIARY OBJECTIVES: I. Explorative biomarker analysis. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive cisplatin intravenously (IV) over 1-4 hours on day 1 and fluorouracil IV continuously over 24 hours on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with complications associated with the central venous access which prevent further infusion of fluorouracil and only after discussion with the Chief Investigator may receive capecitabine twice daily (BID) on days 1-4. ARM B: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks.

Conditions

• Anal Basaloid Carcinoma
• Anal Canal Cloacogenic Carcinoma
• Anal Squamous Cell Carcinoma
• Metastatic Anal Canal Carcinoma
• Recurrent Anal Canal Carcinoma
• Stage IIIB Anal Canal Cancer
• Stage IV Anal Canal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine
DRUG	Carboplatin	Given IV
DRUG	Cisplatin	Given IV
DRUG	Fluorouracil	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-08-23
• Primary completion: 2021-08-31
• Completion: 2023-08-01
• First posted: 2015-09-25
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States