Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Polyglutamate Camptothecin in Treating Patients With Advanced Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-03002 CTI-PGC101, NCT00059917

Objectives

1. Determine the maximum tolerated dose of polyglutamate camptothecin (CT-2106) in patients with advanced malignancies.
2. Determine the tolerability of this drug in these patients.
3. Determine the safety of this drug in these patients.
4. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
5. Determine the disease response in patients treated with this drug.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

McNamara MV, Doroshow JH, Dupont J, et al.: Preliminary pharmacokinetics of CT-2106 (polyglutamate camptothecin) in patients with advanced malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-2073, 145s, 2004.

Springett GM, Takimoto C, McNamara M, et al.: Phase I study of CT-2106 (polyglutamate camptothecin) in patients with advanced malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-3127, 226s, 2004.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Jakob Dupont, MD, Protocol chair		Ph: 212-639-8984; 800-525-2225 Email: dupontj@mskcc.org

Registry Information
Official Title		Phase I Study of CT-2106 in Patients with Advanced Malignancy
Trial Start Date		2003-01-14
Registered in ClinicalTrials.gov		NCT00059917
Date Submitted to PDQ		2003-03-12
Information Last Verified		2005-04-06
NCI Grant/Contract Number		P30-CA08748

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