PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors

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

Summary

RATIONALE: Drugs used in chemotherapy, such as PR-104, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with docetaxel or gemcitabine in treating patients with solid tumors.

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

Details

• Lead Sponsor: Proacta, Incorporated
• Treatments: Docetaxel; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor malignancy

• Treatment with either docetaxel or gemcitabine hydrochloride in combination with an investigational agent is reasonable

• Measurable or evaluable disease

PATIENT CHARACTERISTICS:

• ECOG performance status of 0-1

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9.0 g/dL (red blood cell transfusion allowed)

• Bilirubin normal

• ALT and AST ≤ 2.5 times upper limit of normal (ULN)

• Creatinine ≤ 1.5 times ULN

• PT/INR or aPTT ≤ 1.1 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after completion of study therapy

• No evidence of any other significant medical disorder, including uncontrolled infection or infection requiring a concurrent parenteral antibiotic, or laboratory finding that, in the opinion of the investigator, would preclude study compliance

• No known HIV positivity

• No hepatitis B surface antigen positivity

• No hepatitis C positivity with abnormal liver function test

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to > 25% of bone marrow

• No prior high-dose chemotherapy (including conditioning for either myeloablative or nonmyeloablative transplantation)

• No more than 3 prior chemotherapy regimens

• More than 4 weeks since prior major surgery

• More than 4 weeks since prior investigational or traditional anticancer therapy (including radiotherapy) (6 weeks for nitrosoureas and mitomycin C)

• The following medications/treatments are not permitted during the trial:

• Any other licensed or investigational anticancer treatment

• Prophylactic hematopoietic growth factors

• Irradiation therapy (palliative or therapeutic) unless given in the absence of tumor progression

• Concurrent systemic steroids allowed provided the patient is on a stable dose for ≥ 2 weeks prior to study treatment

• Concurrent androgen-deprivation therapy allowed