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

NCT00459836 | Completed Phase 1

• 3 other identifiers: PR104-1003PROACTA-PR-104-1003PROACTA-WIRB-20070094
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of PR-104

Secondary Outcomes (5)

• Safety of PR-104 as measured by CTCAE v3.0 criteria

• Dose-limiting toxicity of PR-104

• Pharmacokinetics of PR-104 and its alcohol metabolite in the blood

• Pharmacokinetics of gemcitabine and docetaxel in the presence of PR-104

• Antitumor activity

Interventions

PR-104 DRUG

docetaxel DRUG

gemcitabine hydrochloride DRUG

laboratory biomarker analysis OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Proacta, Incorporated: lead

Study Sites (3)

Proacta, Incorporated

San Diego, California, 92121, United States

Location

University of Auckland Cancer Center

Auckland, New Zealand

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Related Publications (1)

• McKeage MJ, Jameson MB, Ramanathan RK, Rajendran J, Gu Y, Wilson WR, Melink TJ, Tchekmedyian NS. PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours. BMC Cancer. 2012 Oct 25;12:496. doi: 10.1186/1471-2407-12-496.

  PMID: 23098625 DERIVED

MeSH Terms

Interventions

PR-104; Docetaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Terri J. Melink, NP, MSN, ANP

  Proacta, Incorporated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2009
• Last Updated: March 2, 2011

Record last verified: 2011-02

Locations

NZ (2); US (1)