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A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose Escalation, Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Colorectal Neoplasms, Diarrhea

Thank you

Trial Information

A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose Escalation, Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer


CPT-11/5-FU/LV is an active combination agent in the treatment of colorectal cancer, but one
of its dose-limiting toxicities is diarrhea. PHY906 has been shown to reduce the severity
of CPT-11–induced toxicity without compromising antitumor efficacy in in vivo animal models.
Additionally, there has been a long historical experience in the Far East demonstrating
safety of PHY906 in humans. Thus, we are conducting this double-blind, placebo-controlled
study to evaluate the safety and tolerability of PHY906. This dose escalation study will
also examine the effect of PHY906 (1.2, 2.4, and 3.6 g/day) on the pharmacokinetics of
CPT-11 and 5-FU after concomitant administration with CPT-11, 5-FU, and LV, and on the
severity of CPT-11–induced toxicities such as diarrhea.

Inclusion Criteria


Inclusion Criteria

Patients must:

- be between 18 and 75 years of age, inclusive, at the time of enrollment.

- have advanced colorectal carcinoma, which may be either measurable or non-measurable.

- not have received either CPT-11, FU, or other cytotoxic chemotherapy agents in any
setting (including adjuvant) within 1 year prior to screening.

- have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

- use an effective contraceptive method if the patients are of reproductive potential
while enrolled in the study, since the potential effects of the herbs on a developing
fetus are unknown.

- have an estimated life expectancy of at least 20 weeks.

- provide written informed consent.

- have adequate organ function as indicated by the following laboratory values; these
laboratory values must be obtained within 14 days prior to study enrollment:

- Bone marrow reserve: absolute granulocyte count (AGC) more than or equal to 1.5 X
10(to the power of 9)/L, platelet count more than or equal to 100 X 10 (to the power
of 9)/L, and hemoglobin level more than or equal to 9 g/dL.

- Hepatic function: serum total bilirubin concentration no greater than 1.5 mg/dL,
aspartate transaminase (AST or serum glutamic-oxaloacetic transaminase [SGOT]), and
alanine transaminase (ALT or serum glutamic-pyruvic transaminase [SGPT]) levels no
greater than grade 2 toxicity as determined from the NCI-CTC version 2.0.

- Renal function: serum creatinine level no greater than grade 2 toxicity as
determined from the CTC version 2.0.

Exclusion Criteria

Patients who have or are:

- Gilbert syndrome (familial, non-hemolytic, acholuric jaundice).

- patients with enterostomies.

- untreated brain metastases or deteriorating neurological function after the
completion of cranial irradiation.

- a woman who is currently pregnant and/or breast-feeding.

- active infections or any serious systemic disorder that, in the opinion of the
principal investigator, are incompatible with the study product and/or procedures.

- used an investigational agent within 4 weeks of study entry.

- a known hypersensitivity to the study medication, its excipients, its analogs, or any
of the component herbs.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Wayne D Brenckman, Jr., MD

Investigator Role:

Study Director

Investigator Affiliation:

Inveresk Research

Authority:

United States: Food and Drug Administration

Study ID:

PHY906-2000-1

NCT ID:

NCT00036517

Start Date:

February 2002

Completion Date:

March 2003

Related Keywords:

  • Colorectal Neoplasms
  • Diarrhea
  • Stage III and Stage IV colorectal cancer
  • diarrhea
  • reduce
  • alleviate
  • modulate
  • Saltz regimen
  • CPT-11
  • irinotecan
  • camptosar
  • 5-fluorouracil
  • leucovorin
  • 5-FU
  • LV
  • chemotherapy
  • side effect
  • toxicity
  • botanical drug
  • herbal medicine
  • chinese herbal medicine
  • traditional chinese medicine
  • TCM
  • oral dose
  • oral administration
  • concomitant use
  • Neoplasms
  • Colorectal Neoplasms
  • Diarrhea

Name

Location

Cancer Centers of the CarolinasGreenville, South Carolina  29605
Weill Cornell Medical CenterNew York, New York  10021
VA CT Cancer CenterWest Haven, Connecticut  06516