NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewBiotics
• Treatments: Brivudine; Phosphoramidic acid

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic or recurrent colorectal adenocarcinoma that has progressed during or within 6 months of fluoropyrimidine-based therapy

• Prior treatment with irinotecan with or without fluorouracil

• Evaluable or measurable disease

• Uni-dimensionally measurable disease allowed provided CEA is at least 2 times the upper limit of normal

• No meningeal or CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 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 less than 1.5 mg/dL (regardless of liver metastases)

• AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present)

• PT and INR normal

• PTT normal

Renal:

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance greater than 50 mL/min

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No known hypersensitivity to NB1011 or any excipient or vehicle in its formulation

• No active or uncontrolled serious bacterial, viral, fungal, or parasitic infection

• No prior or concurrent alcohol abuse or dependency

• No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No concurrent medical or psychological condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• Recovered from prior anticancer chemotherapy

• No concurrent fluoropyrimidine-based or thymidylate synthase inhibitor agents

Endocrine therapy:

• Not specified

Radiotherapy:

• Recovered from prior anticancer radiotherapy

• No concurrent radiotherapy except palliative radiotherapy (to control a fracture or pain) provided index lesions are not involved

Surgery:

• Recovered from prior anticancer surgery

Other:

• At least 30 days since prior investigational agents

• No other concurrent anticancer therapy

• No concurrent disulfiram