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Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate, Indomethacin and Recombinant Human Interferon-Gamma in Advanced Colorectal Cancer


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

Thank you

Trial Information

Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate, Indomethacin and Recombinant Human Interferon-Gamma in Advanced Colorectal Cancer


PRIMARY OBJECTIVES:

I. To determine in a Phase I study the toxicity of flurouracil (FU) when given in escalating
doses in combination with fixed doses of phenlylbutyrate (PB), indomethacin and recombinant
human interferon-gamma (rhIFNg) to patients with advanced colorectal cancer.

II. To determine in a Phase II study the efficacy of FU in combination with PB, indomethacin
and rhIFNg in patients with advanced colorectal cancer.

OUTLINE: This is a dose-escalation study of fluorouracil (5-FU).

Phase I: Patients receive 5-FU IV over 24 hours on day 1; phenylbutyrate IV over 120 hours
and oral indomethacin daily on days 2-6; and interferon gamma subcutaneously on days 2, 4,
and 6. Courses repeat weekly in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose at which less than 2 of 6 patients
experience dose-limiting toxicity (DLT).

Phase II :Patients receive 5-FU, phenylbutyrate, indomethacin, and interferon gamma as in
phase I at the MTD.

Patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for the phase I portion of this
study and approximately 46 patients will be accrued for the phase II portion of this study.


Inclusion Criteria:



- Stage IV colorectal adenocarcinoma, excluding brain metastases

- Histological confirmation of colorectal adenocarcinoma

- Previously untreated patients

- Previously treated patients

- For the Phase I trial, no limitations

- For the Phase II trial, previous treated limited to adjuvant radiation and/or
chemotherapy which is completed at least 12 months before documentation of
metastatic disease; patients may not have received chemotherapy for metastatic
disease

- For the Phase I trial, patients may have measurable disease or unmeasurable disease;
for the Phase II trial, patients must have measurable disease in at least two
dimensions on x-rays, CT scan or MRI

- Expected survival of at least 16 weeks

- Performance status of >= 70% (Karnofsky)

- WBC >= 3000 uL

- Platelet count >= 100,000/uL

- Bilirubin =< 2 x ULN

- Creatinine =< 2 x ULN

- Not pregnant and not lactating; women of child bearing age must have negative
pregnancy test (beta-hcg)

- No allergies to interferon-gamma or E.coli derived products

- No serious medical intercurrent medical illnesses, including Class III or IV
cardiovascular disease; patient may not be dependent on immunosuppressive drugs
including corticosteroids, and may not receive these drugs for the entire duration of
the study

- No diarrhea, and with adequate oral intake

- Patients of child-bearing age and potential must agree to use adequate birth control
other than oral contraceptives for the entire duration of the study

- No previous or concurrent malignancy except inactive nonmelanoma skin cancer, in situ
carcinoma of the cervix, grade 1 bladder cancer, or other cancers if the patient has
been disease free for >= 5 years

- Patients must be oriented and rational, and aware of the investigational nature of
the study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of flurouracil (FU) when given in escalating doses in combination with fixed doses of phenlylbutyrate (PB), indomethacin and recombinant human interferon-gamma (rhIFNg) to patients with advanced colorectal cancer (Phase I)

Outcome Time Frame:

1 week

Safety Issue:

Yes

Principal Investigator

Max Sung

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2013-00038

NCT ID:

NCT00002796

Start Date:

May 1997

Completion Date:

Related Keywords:

  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Cystadenocarcinoma
  • Colorectal Neoplasms

Name

Location

Mount Sinai Medical CenterNew York, New York  10029