Know Cancer

or
forgot password

An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Chronic Myeloproliferative Disorders, Colorectal Cancer, Head and Neck Cancer, Leukemia, Lung Cancer, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic/Myeloproliferative Diseases, Prostate Cancer, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies


OBJECTIVES:

- Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in
patients with advanced malignancies.

- Determine the dose-limiting toxicity of this regimen in these patients.

- Determine the safety and tolerability of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Evaluate the tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2
groups.

Group A:

- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and
10 and doxorubicin IV over 15 minutes on day 8.

- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over
15 minutes.

- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15
minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment
repeats every 21 days.

Group B:

- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on day 1 and
doxorubicin IV over 15 minutes on day 8.

- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over
15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3.

- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin and
motexafin gadolinium as in group A.

Treatment in both groups continues for up to 6 courses in the absence of disease
progression, unacceptable toxicity, or a cumulative doxorubicin dose of 450 mg/m^2.

Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose
at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 and 2 months.

PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced malignancy that is considered incurable

- Recurrent or metastatic disease

- Relapsed solid tumors include, but are not limited to the following sites:

- Lung

- Breast

- Colon

- Prostate

- Head and neck

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex

- Not specified

Menopausal status

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- AST and ALT no greater than 2 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- LVEF greater than 45% at rest

- No prior myocardial infarction

- No congestive heart failure

- No clinically significant ventricular arrhythmias

Other:

- No history of HIV infection

- No history of porphyria

- No glucose-6-phosphate dehydrogenase deficiency

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 28 days since prior chemotherapy

- No prior lifetime cumulative doxorubicin exposure of more than 300 mg/m^2

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 28 days since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- No concurrent surgery

Other:

- At least 14 days since prior multidrug resistance-modulating drugs (e.g., PSC833 or
cyclosporine)

- No other concurrent antineoplastic or investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Markus Renschler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Pharmacyclics

Authority:

United States: Federal Government

Study ID:

CDR0000069322

NCT ID:

NCT00036790

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Colorectal Cancer
  • Head and Neck Cancer
  • Leukemia
  • Lung Cancer
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic/Myeloproliferative Diseases
  • Prostate Cancer
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • isolated plasmacytoma of bone
  • extramedullary plasmacytoma
  • refractory multiple myeloma
  • Waldenstrom macroglobulinemia
  • stage III multiple myeloma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • small intestine lymphoma
  • unspecified adult solid tumor, protocol specific
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • refractory hairy cell leukemia
  • chronic myelomonocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • acute undifferentiated leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • prolymphocytic leukemia
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • chronic eosinophilic leukemia
  • chronic neutrophilic leukemia
  • recurrent non-small cell lung cancer
  • recurrent small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent lip and oral cavity cancer
  • stage III lip and oral cavity cancer
  • stage IV lip and oral cavity cancer
  • recurrent paranasal sinus and nasal cavity cancer
  • stage III paranasal sinus and nasal cavity cancer
  • stage IV paranasal sinus and nasal cavity cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent hypopharyngeal cancer
  • stage III hypopharyngeal cancer
  • stage IV hypopharyngeal cancer
  • recurrent laryngeal cancer
  • stage III laryngeal cancer
  • stage IV laryngeal cancer
  • recurrent oropharyngeal cancer
  • stage III oropharyngeal cancer
  • stage IV oropharyngeal cancer
  • recurrent nasopharyngeal cancer
  • stage III nasopharyngeal cancer
  • stage IV nasopharyngeal cancer
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Breast Neoplasms
  • Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Leukemia
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myeloproliferative Disorders
  • Prostatic Neoplasms
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236