Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma of the Appendix, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.


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 =< 1.5 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Difference in the rate of grade 3 or 4 hematologic toxicities (leukopenia, thrombocytopenia, and neutropenia) between the mitomycin C and oxaliplatin treatments

Outcome Description:

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.

Outcome Time Frame:

Within 4 weeks of surgery

Safety Issue:

Yes

Principal Investigator

Edward Levine

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CCCWFU 59109

NCT ID:

NCT01580410

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Carcinoma of the Appendix
  • Primary Peritoneal Cavity Cancer
  • Appendiceal Neoplasms
  • Carcinoma
  • Peritoneal Neoplasms
  • Colonic Neoplasms

Name

Location

UPMC Hillman Cancer CenterPittsburgh, Pennsylvania  15232
M D Anderson Cancer CenterHouston, Texas  77030
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157