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Anal Basaloid CarcinomaPhase 2InterAACTNCT02560298

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

A Phase 2 study testing Capecitabine, Carboplatin and Cisplatin in people with Anal Basaloid Carcinoma and Anal Canal Cloacogenic Carcinoma, run by ECOG-ACRIN Cancer Research Group at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteUnited States
Study dates
23 Aug 2016to Aug 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
  • Previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable locally recurrent or metastatic tumors (previous use of radiotherapy in this setting is not an exclusion criterion if: 1) non-irradiated target tumor lesions are present at randomization for the purpose of tumor response assessment or 2) in the absence of non-irradiated target tumor lesions, progression of the irradiated tumor lesions according to the RECIST criteria version 1.1 is documented)
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  • 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
  • Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial
  • Known hypersensitivity to any of the study drugs or excipients
  • Known peripheral neuropathy > grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
  • Pre-existing hearing impairment
  • Patients planning for a live vaccine
  • Pregnant or lactating females

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate best overall response rate (ORR).

SECONDARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Capecitabine, Carboplatin, Cisplatin, Fluorouracil, Laboratory Biomarker Analysis
Medical subject headings
Anal Canal Carcinoma, Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • FluorouracilDrug

    Also called 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02560298
Study groupRoleWhat they receive
Arm A (cisplatin, fluorouracil or capecitabine)ExperimentalPatients 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.
Receives: Drug: Capecitabine; Drug: Cisplatin; Drug: Fluorouracil; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment
Arm B (paclitaxel, carboplatin)ExperimentalPatients 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.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 3 years

Secondary outcomes (11)

  1. Anti-tumor activity and magnitude of response

    Anti-tumor activity and magnitude of response will be captured by waterfall plot analyses. The percentage change in tumor size from baseline to the time of best response will be plotted by patients (ordered from worst to best) and bars colored according to best response.

    Measured: Up to 3 years

  2. 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

    The ORR of non-irradiated lesions 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.

    Measured: Up to 3 years

  3. Changes in QOL

    QOL will be evaluated using the European Organization for Research and Treatment of Cancer Core Quality of Life and EuroQOL-5 dimension-5 level questionnaires. Differences from baseline will be compared between arms of the study using the two sample t-test or Wilcoxon non-parametric method as appropriate.

    Measured: Baseline to up to 3 years

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

    DCR 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.

    Measured: At 24 weeks post treatment start

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

    DCR 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.

    Measured: At 12 weeks post treatment start

  6. Feasibility in terms of proportion of centers that successfully recruit at least one patient

    The proportion of centers engaging will be presented with 95% confidence intervals.

    Measured: Up to 36 months

  7. Feasibility in terms of recruitment rate

    The recruitment rate will be calculated overall centers and by country and center.

    Measured: Up to 36 months

  8. OS

    The Kaplan Meier estimates of OS over time and median OS with associated 95% confidence intervals will be presented by treatment and (as exploratory endpoint) compared using a log rank test. Cox multivariate regression analysis will be used (as exploratory analysis) to calculate the hazard ratio between treatments along with its 95% confidence interval. The treatment effect will be adjusted for the stratification factors and other identified prognostic factors (e.g. time to disease relapse \& whether pre-treated with platinum) in a multivariate setting.

    Measured: From the date of randomization to the date of death from any cause, assessed up to 12 months

  9. PFS

    The Kaplan Meier estimates of PFS over time and median PFS with associated 95% confidence intervals will be presented by treatment and (as exploratory endpoint) compared using a log rank test. Cox multivariate regression analysis will be used (as exploratory analysis) to calculate the hazard ratio between treatments along with its 95% confidence interval. The treatment effect will be adjusted for the stratification factors and other identified prognostic factors (e.g. time to disease relapse \& whether pre-treated with platinum) in a multivariate setting.

    Measured: From the date of randomization to the date of confirmed clinical/radiological progression or death from any cause, assessed up to 12 months

  10. Proportion of patients experiencing grade 3-5 toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    The proportion of patients experiencing grade 3-5 toxicity will be compared on a regimen basis using the chi-squared test. Fisher's exact test will be used when expected cell frequencies are < 5.

    Measured: Up to 3 years

  11. Sensitivity analysis of ORR

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2015 (estimated)
  2. Study start23 Aug 2016
  3. Primary completion31 Aug 2021
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560298
Sponsor's protocol ID
EA2133
Other IDs
NCI-2015-00771, EA2133, 13/LO/1463, CCR 3847, 2013-001949-13, InterAACT CCR 3847, 3847, EA2133
Acronym
InterAACT
Status last verified
Jun 2023
First submitted
24 Sep 2015
Last updated
22 Jun 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Carboplatin and Cisplatin in people with Anal Basaloid Carcinoma and Anal Canal Cloacogenic Carcinoma, run by ECOG-ACRIN Cancer Research Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best ORR defined as the percentage of patients achieving confirmed partial (PR) or complete responses (CR) as per RECIST v1.1 (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02560298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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