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Carcinoma of the AppendixPhase 2NCT01580410

Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix

A Phase 2 study testing mitomycin C, oxaliplatin and therapeutic conventional surgery in people with Carcinoma of the Appendix and Primary Peritoneal Cavity Cancer, run by Wake Forest University Health Sciences at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
mitomycin C, oxaliplatin and therapeutic conventional surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
3 sitesUnited States
Study dates
May 2009to Nov 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must have histologically or cytologically confirmed peritoneal surface malignancies from primary appendiceal tumors
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >=100,000/mcL
  • Total bilirubin =< 1.5 mg/dL
  • Creatinine =< 2.0 mg/dL
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  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 X institutional upper limit of normal
  • Alkaline phosphatase =< 3 X institutional upper limit of normal
  • Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy, or other antineoplastic therapy
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) for the duration of study participation and for 90 days following HIPEC
  • Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
  • Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol

Who cannot join

  • Patients with an active infection or with a fever >= 101.3 degrees Fahrenheit (F) within 3 days of the first scheduled day of protocol treatment
  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Patients with carcinoid tumors
  • Patients with active central nervous system (CNS) metastases
  • Patients with known hypersensitivity to any of the components of oxaliplatin or mitomycin C
  • History of prior malignancy within the past 5 years, except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen (PSA) of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
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  • Patients who received radiotherapy to more than 25% of their bone marrow
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant/nursing women are excluded from this study because oxaliplatin is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin, breastfeeding should be discontinued if the mother is treated with oxaliplatin or mitomycin C
  • Known human immunodeficiency virus (HIV), hepatitis B or C-positive patients (active, previously treated or both)
  • Peripheral neuropathy >= grade 2
  • History of allogenic transplant
  • History of prior HIPEC
  • Evidence of metastatic disease outside of the abdomen

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After HIPEC With Oxaliplatin or Mitomycin C in Patients With Appendiceal Tumors

This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the toxicity profiles within 4 weeks of surgery of oxaliplatin and mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy in patients with peritoneal surface malignancies from primary appendiceal tumors.

SECONDARY OBJECTIVES:

  1. To compare the time to progression in patients treated with oxaliplatin vs. mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy for surface malignancies from primary appendiceal tumors.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo surgical cytoreduction and receive mitomycin C by hyperthermic intraperitoneal chemotherapy (HIPEC).

Arm II: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, and 36 months.

Being tested
mitomycin C, oxaliplatin, therapeutic conventional surgery, quality-of-life assessment, hyperthermic intraperitoneal chemotherapy
Medical subject headings
Appendiceal Neoplasms

What participants receive

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

  • mitomycin CDrug

    Also called MITC, MITO, MITO-C, Mitocin-C

    Given by HIPEC

  • oxaliplatinDrug

    Also called 1-OHP, Dacotin, Dacplat, Eloxatin

    Given by HIPEC

  • therapeutic conventional surgeryProcedure or surgery

    Undergo surgery

  • quality-of-life assessmentOther

    Also called quality of life assessment

    Ancillary studies

  • hyperthermic intraperitoneal chemotherapyDrug

    Undergo HIPEC

Study groups in NCT01580410
Study groupRoleWhat they receive
Arm I (mitomycin C)ExperimentalPatients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
Receives: Drug: mitomycin C; Procedure: therapeutic conventional surgery; Other: quality-of-life assessment; Drug: hyperthermic intraperitoneal chemotherapy
Arm II (oxaliplatin)ExperimentalPatients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
Receives: Drug: oxaliplatin; Procedure: therapeutic conventional surgery; Other: quality-of-life assessment; Drug: hyperthermic intraperitoneal chemotherapy

What is being measured

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

  1. The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments

    If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.

    Measured: Within 4 weeks of surgery

Secondary outcomes (3)

  1. The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years

    Measured: Time to first progression unless the patient's resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years

  2. The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years

    Measured: Interval between surgery and death or date of last contact, assessed up to 3 years

  3. Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)

    The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.

    Measured: Throughout study completion, 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 posted19 Apr 2012 (estimated)
  2. Study startMay 2009
  3. Primary completionOct 2015
  4. Study completionNov 2016

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
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01580410
Sponsor's protocol ID
IRB00009326
Other IDs
NCI-2009-00947, CCCWFU 59109
Status last verified
Jun 2018
First submitted
17 Apr 2012
Last updated
3 Jul 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mitomycin C, oxaliplatin and therapeutic conventional surgery in people with Carcinoma of the Appendix and Primary Peritoneal Cavity Cancer, run by Wake Forest University Health Sciences at 3 sites 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 12 inclusion and 14 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: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 21 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments (time frame: Within 4 weeks of surgery). 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 NCT01580410.

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 3 Jul 2018.

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