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

NCT02560298 | Unknown Phase 2

• 8 other identifiers: EA2133NCI-2015-0077113/LO/1463CCR 38472013-001949-13InterAACT CCR 38473847U10CA180820
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Best ORR defined as the percentage of patients achieving confirmed partial (PR) or complete responses (CR) as per RECIST v1.1

  The ORR will be summarized as the percentage (including 95% confidence intervals) of responders and presented by treatment group and will be compared (as exploratory endpoint) between treatment groups using a chi-squared test.

  Up to 3 years

Secondary Outcomes (11)

• Anti-tumor activity and magnitude of response

  Up to 3 years

• 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

  Up to 3 years

• Changes in QOL

  Baseline to up to 3 years

• DCR defined as CR, PR, or SD assessed according to RECIST criteria v1.1

  At 24 weeks post treatment start

• DCR defined as CR, PR, or stable disease (SD) assessed according to RECIST criteria v1.1

  At 12 weeks post treatment start

Other Outcomes (1)

• Changes in expression of tumor biomarkers

  Up to 3 years

Study Arms (2)

Arm A (cisplatin, fluorouracil or capecitabine)

EXPERIMENTAL

Patients receive cisplatin 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 receive capecitabine BID on days 1-4.

Drug: Capecitabine; Drug: Cisplatin; Drug: Fluorouracil; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Arm B (paclitaxel, carboplatin)

EXPERIMENTAL

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.

Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Quality-of-Life Assessment

Interventions

Capecitabine DRUG

Also known as: Ro 09-1978/000, Xeloda

Arm A (cisplatin, fluorouracil or capecitabine)

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm B (paclitaxel, carboplatin)

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm A (cisplatin, fluorouracil or capecitabine)

Fluorouracil DRUG

Given IV

Also known as: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Arm A (cisplatin, fluorouracil or capecitabine)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (cisplatin, fluorouracil or capecitabine); Arm B (paclitaxel, carboplatin)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm B (paclitaxel, carboplatin)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (cisplatin, fluorouracil or capecitabine); Arm B (paclitaxel, carboplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inoperable, locally recurrent or metastatic disease (tumor resectability should be assessed by a local surgeon or multidisciplinary team)
• Histological or cytological confirmation of epidermoid anal carcinoma (includes squamous, basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
• 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)
• Previous systemic chemotherapy is permitted if administered as induction treatment (=\< 2 cycles) before definitive chemoradiotherapy for early stage disease and there is no evidence of tumor progression during or after treatment completion
• Human immunodeficiency virus positive (HIV+) patients will be considered eligible if they are on highly active anti-retroviral therapy (HAART) and have a cluster of differentiation (CD)4 count of \>= 200/ul (HIV+ patients who are on HAART and have a CD4 count \< 200/ul are eligible if the plasma viral load is below the level of detection according to the local assay)
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/l
• Platelets \>= 100 x 10\^9/l
• Hemoglobin (Hb) \>= 9 g/dl for males and \>= 8 g/dl for females
• Creatinine clearance \>= 50 ml/minute
• Serum bilirubin =\< 1.5 x upper limit of normal (ULN)
• Alanine transaminase (ALT) or aspartate transaminase (AST) =\< 3 x ULN (if liver metastases are present, serum transaminases =\< 5 x ULN are permitted)
• Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy
• Life expectancy of at least 3 months

You may not qualify if:

• Tumors of adenocarcinoma, melanoma, small cell and basal cell histology are excluded
• Locally recurrent tumor which is amenable to curative resection (as deemed by a local surgeon or multidisciplinary team)
• Tumor relapse/progression within 6 months of completion of a cisplatin-based chemoradiotherapy regimen for the treatment of early stage tumors
• Previous administration of \> 2 cycles of systemic chemotherapy as induction treatment before definitive chemoradiotherapy for early stage disease
• Tumor progression during or immediately after completion of =\< 2 cycles of systemic chemotherapy as induction treatment before definitive chemoradiotherapy for early stage disease
• Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study
• Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease
• Major surgery performed \< 28 days from treatment start
• Palliative radiotherapy completed =\< 7 days from treatment start
• Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months); any history of clinically significant cardiac failure
• History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
• HIV+ patients who are not on HAART or have a CD4 count of \< 200/ul in the presence of detectable plasma viral load according to the local assay
• Known history of active hepatitis B or hepatitis C infection
• Serious active infection requiring intravenous (i.v.) antibiotics at enrollment
• Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Anal Canal Carcinoma; Anus Neoplasms

Interventions

Capecitabine; Carboplatin; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Fluorouracil; dehydroftorafur; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Cathy Eng

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: August 23, 2016
• Primary Completion: August 31, 2021
• Study Completion: August 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)