Trial record 16 of 19 for:    Thrombocytopenia | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01580410
First received: April 17, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma of the Appendix
Primary Peritoneal Cavity Cancer
Drug: mitomycin C
Drug: oxaliplatin
Procedure: therapeutic conventional surgery
Other: quality-of-life assessment
Drug: hyperthermic intraperitoneal chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Difference in the rate 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Comparison of disease-free survival between the two treatment arms [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Comparison of overall survival between the two treatment arms [ Time Frame: Interval between surgery and death or date of last contact, assessed up to 3 years ] [ Designated as safety issue: No ]
  • Quality of life as assessed by FACT-G [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: May 2009
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (mitomycin C)
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
Drug: mitomycin C
Given by HIPEC
Other Names:
  • MITC
  • MITO
  • MITO-C
  • Mitocin-C
  • MTC
Procedure: therapeutic conventional surgery
Undergo surgery
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: hyperthermic intraperitoneal chemotherapy
Undergo HIPEC
Experimental: Arm II (oxaliplatin)
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
Drug: oxaliplatin
Given by HIPEC
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP
Procedure: therapeutic conventional surgery
Undergo surgery
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: hyperthermic intraperitoneal chemotherapy
Undergo HIPEC

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580410

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: John H. Stewart    336-716-9127    jhstewar@wfubmc.edu   
Principal Investigator: John H. Stewart         
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: David L. Bartlett    412-692-2852    bartlettdl@msx.upmc.edu   
Principal Investigator: David L. Bartlett         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Keith F. Fournier    713-792-8826    kffourni@mdanderson.org   
Principal Investigator: Keith F. Fournier         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Edward Levine Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01580410     History of Changes
Obsolete Identifiers: NCT00904267
Other Study ID Numbers: CCCWFU 59109, NCI-2009-00947
Study First Received: April 17, 2012
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Appendiceal Neoplasms
Carcinoma
Peritoneal Neoplasms
Cecal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Mitomycins
Mitomycin
Oxaliplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014