Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: nitrocamptothecin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00005820

GUMC-00192

CDR0000067827 (Registry Identifier)

CALGB-99901

U10CA031946 (U.S. NIH Grant/Contract)

CLB-99901

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy.

Full description

OBJECTIVES:

• Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic, hormone refractory prostate cancer.
• Determine time to disease progression and duration of response in this patient population as a result of this treatment regimen.
• Determine the safety, tolerance, and toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study over 2 years.

Enrollment: 35 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate with clinically progressive stage IVA or IVB disease after at least primary androgen ablation with either orchiectomy or LHRH agonist and only one cytotoxic chemotherapy regimen
• Measurable disease with a maximum of 10 measurable lesions OR nonmeasurable disease
• Serum testosterone no greater than 50 ng/mL if no prior bilateral orchiectomy

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• ECOG 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3 (transfusion independent)
• No disseminated intravascular coagulation

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 3 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Fertile patients must use effective contraception
• No currently active second malignancy other than nonmelanoma skin cancers
• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

• See Disease Characteristics
• At least 6 weeks since prior suramin
• At least 4 weeks since other prior chemotherapy
• No prior therapy with camptothecin or any of its analogues

Endocrine therapy:

• Prior second line hormonal therapy allowed
• At least 4 weeks since prior hormonal therapy
• Concurrent treatment with LHRH agonists allowed and required for
• patients without orchiectomy
• No concurrent hormonal therapy except for nondisease related conditions
• Concurrent corticosteroids allowed if on stable dose for at least 6 weeks
• before study
• No concurrent dexamethasone as an antiemetic

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered
• No palliative radiotherapy
• At least 8 weeks since prior strontium 89 or samarium 153

Surgery:

• At least 3 weeks since major surgery and recovered

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

nitrocamptothecin

Experimental group

Description:

Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration.

Treatment:

Drug: nitrocamptothecin