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A Phase I Open-Label Study of Picoplatin in Combination With 5-Fluorouracil and Leucovorin as Initial Therapy in Subjects With Metastatic Colorectal Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

A Phase I Open-Label Study of Picoplatin in Combination With 5-Fluorouracil and Leucovorin as Initial Therapy in Subjects With Metastatic Colorectal Cancer

Subjects will be randomized centrally to treatment with picoplatin administered either every
two or every four weeks and will be assigned a dose of picoplatin dependent on the study
results to date. Each patient will also receive therapy every two weeks with 5-FU and
leucovorin. In each schedule, the cohort size will be 3 subjects, to be expanded to 6
subjects if a dose-limiting toxicity is observed. If not dose-limiting toxicity observed
among the 3 subjects within a cohort, picoplatin dose escalation may proceed, until the
maximum tolerated dose is established.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum.

- Metastatic disease consistent with colorectal adenocarcinoma. Stage M1, and not
amenable to curative surgery. Subjects with only locally persistent or only locally
recurrent disease are not eligible.

- No prior systemic therapy for metastatic cancer. Prior adjuvant chemotherapy with a
5-FU-based treatment regimen not containing oxaliplatin or irinotecan is acceptable
after a treatment-free interval of at least 6 months.

- ECOG performance score (PS) of 0 or 1.

- Life expectancy more than 3 months.

- Subject must have measurable disease, defined by the RECIST criteria.

- At least 28 days must have elapsed since prior surgery except venous access device

- At least 28 days must have elapsed since prior radiotherapy.

- At least 28 days must have elapsed since a prior investigational agent.

- Absolute neutrophil count (ANC) equal to or greater than 1.5 x 10^9/L.

- Platelet count equal to or greater than 100 x 10^9/L.

- Hemoglobin equal or greater than 10g/dL (must be obtained at least 3 days after any

- Serum AST and ALT levels less than or equal to 2.5 times upper limit of normal (ULN)
or less than 5 times ULN if liver involvement is present.

- Serum bilirubin of less than or equal to 1.5 ULN.

- Serum creatinine of less than or equal to ULN.

- Women of childbearing potential must have a negative pregnancy test (serum or urine
beta HCG).

- All subjects must agree to use appropriate birth control methods while on study and
for 1 month after completion of study chemotherapy.

Exclusion Criteria:

- Concurrent use of EGFR inhibitors or anti-VEGF agents.

- No clinically significant obstructive symptoms or intestinal bleeding.

- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a
major symptom (e.g. Crohn's disease, ulcerative colitis, malabsorption syndrome,
Grade 2+ diarrhea of any etiology at baseline).

- History of serious cardiac disease, defined as myocardial infarction within six
months of enrollment, congestive heart failure classified by the New York Heart
Association as class III or IV, uncontrolled cardiac arrhythmias, poorly controlled
or unstable angina, or electrocardiographic evidence of acute ischemia.

- Clinical evidence of brain metastases or central nervous system disease.

- Symptomatic peripheral neuropathy (equivalent to Grade 2 or higher CTCAE toxicity

- Uncontrolled intercurrent illness (e.g. active infection).

- Pregnant or nursing.

- Serious medical or psychiatric illness that could potentially interfere with the
completion of study treatment according to this protocol.

- Malignancy other than colorectal carcinoma within the past 5 years, except,
curatively treated, superficial skin cancer or carcinoma in situ of the cervix or

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

dose-limiting toxicity

Outcome Time Frame:

within the first four weeks of treatment

Safety Issue:


Principal Investigator

Robert Earhart, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Poniard Pharmaceuticals


Russia: Pharmacological Committee, Ministry of Health

Study ID:




Start Date:

April 2006

Completion Date:

June 2010

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • picoplatin
  • chemotherapy
  • Colorectal Neoplasms