Know Cancer

or
forgot password

The Pharmacokinetic and Safety Profile of UCN-01 in Combination With Irinotecan in Solid Tumors (Primarily Lung, Ovarian and GI Cancers)


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

Thank you

Trial Information

The Pharmacokinetic and Safety Profile of UCN-01 in Combination With Irinotecan in Solid Tumors (Primarily Lung, Ovarian and GI Cancers)


OBJECTIVES:

- Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and
irinotecan in patients with advanced solid tumors, primarily lung, ovarian, and
gastrointestinal tumors.

- Determine the acute and chronic toxicity profile of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine, preliminarily, the anti-tumor effect of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1
and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated
at the recommended phase II dose.

Patients are followed at 1 month.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 7-15
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignancy that is metastatic or unresectable and for which
standard curative or palliative therapy does not exist or is no longer effective

- Gastrointestinal, lung, and ovarian malignancies are given priority

- No brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 3 months

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin normal

- AST/ALT no greater than 2.5 times upper limit of normal (ULN)

Renal

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular

- No symptomatic coronary artery disease

- No symptomatic cardiac dysfunction

- No symptoms suggestive of coronary artery disease

- LVEF at least 50%

Pulmonary

- No symptomatic pulmonary dysfunction

- FEV_1 greater than 75% of predicted

- DLCO greater than 75% of predicted

Other

- Amylase no greater than 2 times ULN

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No diabetes mellitus or random glucose more than 200 mg/dL

- No prior allergic reaction attributed to compounds of similar biological or chemical
composition to UCN-01 or irinotecan (including rash and systemic allergic reaction
causing hypotension and respiratory distress)

- No chronic diarrhea (more than 5 stools/day)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 14 days before, during, and for
at least 30 days after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

- Prior UCN-01 and irinotecan allowed

Endocrine therapy

- Not specified

Radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

- No prior mediastinal radiation

Surgery

- Not specified

Other

- At least 14 days since prior warfarin

- No concurrent warfarin unless required for maintaining patency of existing, permanent
IV catheters

- No concurrent commercial or other investigational anticancer agents or therapies

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ross C. Donehower, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

JHOC-J0173, CDR0000257566

NCT ID:

NCT00047242

Start Date:

August 2002

Completion Date:

Related Keywords:

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

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410