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Phase I Study of CT-2106 in Patients With Advanced Malignancy


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

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Trial Information

Phase I Study of CT-2106 in Patients With Advanced Malignancy


OBJECTIVES:

- Determine the maximum tolerated dose of polyglutamate camptothecin (CT-2106) in
patients with advanced malignancies.

- Determine the tolerability of this drug in these patients.

- Determine the safety of this drug in these patients.

- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

- Determine the disease response in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive polyglutamate camptothecin (CT-2106) IV over 10 minutes on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 2 additional courses beyond confirmation of complete response.

Cohorts of 3-6 patients receive escalating doses of CT-2106 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 12-48 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced malignancy

- No active brain metastases (as indicated by clinical symptoms, cerebral edema, or
progressive tumor growth) that have been unstable for at least 8 weeks

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

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

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

- Hemoglobin at least 9 g/dL

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are
present)

Renal

- Creatinine no greater than 1.5 times ULN

- No history of hemorrhagic cystitis

- No history of microscopic hematuria associated with drug therapy or radiotherapy or
of unknown origin

Cardiovascular

- No significant cardiac disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to comply with study schedule and assessments

- No other significant nonmalignant systemic disease

- No active infection

- No other condition that would in the investigator's opinion make the patient an
inappropriate study candidate

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No more than 3 prior chemotherapy regimens

- More than 4 weeks since prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- More than 4 weeks since prior definitive radiotherapy (except for palliative reasons
to sites of nonmeasurable disease, in patients with measurable disease at baseline)

- Concurrent palliative radiotherapy allowed

Surgery

- More than 4 weeks since prior major thoracic or abdominal surgery

Other

- Recovered from prior therapy (except alopecia or stable grade 1 neuropathy)

- More than 4 weeks since prior investigational agents

- No prior myeloablative therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jakob Dupont, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CTI-PGC101

NCT ID:

NCT00059917

Start Date:

January 2003

Completion Date:

May 2005

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021