Know Cancer

or
forgot password

A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors


OBJECTIVES:

I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with
advanced solid tumors.

II. Determine the toxicity and safety profile of this regimen in these patients.

III. Determine the pharmacokinetic profile of this regimen in this patient population.

OUTLINE: This is a dose-escalation study.

Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV
continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the
maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-58 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven solid tumor for which gemcitabine is a treatment option or for
which no effective therapy exists

- Previously untreated disease allowed

- No large and potentially symptomatic pericardial effusion or undrained pleural
effusion (with or without pleurodesis)

- No CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 2,000/mm3

- Platelet count at least 100,000/mm3

- No prior thrombotic events

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No clinically significant cardiac disease

- No prior deep venous thrombus

- No prior arterial vascular event

- No prior myocardial infarction

- No unstable angina

- No prior transient ischemic attack or cerebrovascular accident

- No cardiac arrhythmias that could be related to cardiac ischemia

Pulmonary:

- No clinically significant pulmonary disease

- No history of pulmonary embolism

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection

- No severe malnutrition or intractable emesis

- No chronic diarrheal disease within the past 6 months

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- No more than 1 prior chemotherapy regimen

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

- Prior gemcitabine or flavopiridol allowed

- No other concurrent chemotherapy

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy to more than 50% of bone marrow

- No concurrent radiotherapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Geoffrey Shapiro, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

00-166

NCT ID:

NCT00007917

Start Date:

January 2001

Completion Date:

October 2010

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115