Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

Sponsor

Threshold Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00102752

Collaborator

PPD (Industry)

Enrollment

Locations

30.9

Duration (Months)

5.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Pancreatic Neoplasms	Drug: Glufosfamide Drug: Gemcitabine	Phase 1/Phase 2

Detailed Description

This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.

Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Overall objective response rate []

Secondary Outcome Measures

Overall survival []
6- and 12- month survival []
Progression-free survival []
Duration of objective response []
Serum CA-19-9 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 18 years of age
Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
Recovered from reversible toxicities of prior therapy
Karnofsky performance status ≥70
Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose
Ability to understand the purposes and risks of the study and provide written informed consent.

Exclusion Criteria:

Prior chemotherapy for metastatic/locally advanced pancreatic cancer
Prior administration of gemcitabine
Radiation therapy within 28 days prior to study start
Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 days prior to study start
Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
Active, clinically significant infection requiring antibiotics
Known HIV positive or active hepatitis B or C
History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
Major surgery within 3 weeks of the start of study treatment, without complete recovery
Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)
Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain),
ANC <1500/μL,
Platelet count <100,000/μL,
Total bilirubin > 1.5 ×ULN,
AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases),
Serum creatinine > 2 mg/dL,
Creatinine clearance < 60 mL/min (calculated)
Females who are pregnant or breast-feeding
Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
Concomitant disease or condition that could interfere with the conduct of the study
Unwillingness or inability to comply with the study protocol for any other reason

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center	Tucson	Arizona	United States	85724
2	Indiana Cancer Center	Indianapolis	Indiana	United States	46202
3	Norton Healthcare Cancer Center	Louisville	Kentucky	United States	40202
4	Hospital de Doenças Cardiovasculares - Biocor	Nova Lima	BH	Brazil	34000-000
5	Hospital Mãe de Deus	Porto Alegre	RS	Brazil	90880-480
6	Hospital Nossa Senhora da Conceição	Porto Alegre	RS	Brazil	91350-200
7	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	SP	Brazil	14784-400
8	Universidade Federal de São Paulo - Hospital São Paulo	São Paulo	SP	Brazil	04023-900
9	Hospital Israelita Albert Einstein	São Paulo	SP	Brazil	05651-901