Doxil Topotecan Doublet Cancer Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252889
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : January 27, 2009
Johnson & Johnson
Information provided by:
Christiana Care Health Services

Brief Summary:

The primary objective is to determine the nature and degree of the toxicity of weekly dosing of topotecan in escalating dose levels by cohorts of 3-6 patients in combination with a fixed dose of pegylated liposomal doxorubicin (Doxil).

The secondary objective is to determine the activity of weekly topotecan and pegylated liposomal doxorubicin in advanced solid tumors.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Pancreatic Cancer Head and Neck Cancer Gastric Cancer Esophageal Cancer Drug: Topotecan and pegylated doxorubicin Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GSK - Doublet: A Phase I Study of Pegylated Liposomal Doxorubicin (Doxil) and Weekly Intravenous Topotecan in Patients With Advanced Solid Tumors
Study Start Date : May 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : June 2008

Intervention Details:
  • Drug: Topotecan and pegylated doxorubicin
    Doxil 40 mg/m2 day 1 and topotecan was to be escalated in cohorts of patients
    Other Name: Hycamptin Topoisomerase I inhibitor

Primary Outcome Measures :
  1. Parameters of response: tumor measurement: Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: every other cycle ]
  2. Survival is the observed length of life from the initiation of treatment to death or the date of last contact [ Time Frame: follow up until death or loss of contact ]
  3. Subjective parameters including ECOG performance status, specific symptoms, and side effects are graded according to standard Common Terminology Criteria for Adverse Events (CTCAE) v.30 criteria. [ Time Frame: every cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ECOG functional status of 2 or better is required.
  • The patient should be able to provide informed consent.
  • Prior treatment with Doxil or topotecan is not permitted.
  • Prior treatment with doxorubicin is permitted if the total dose was 350 mg/m2 or less. Prior treatment with epirubicin is permitted if the total dose was 560 mg/m2.
  • Patients with controlled brain metastases will be considered eligible for therapy (i.e. metastases surgically removed; or irradiated metastases with stable neurologic function).
  • Patients must have measurable disease (the presence of at least one measurable lesion).
  • If previously irradiated lesions are to be used to measure response, documented growth of the lesions must have been observed following completion of radiation therapy.
  • Patients must have a life expectancy of at least four weeks.
  • Hematologic criteria: patients must have absolute neutrophil count (ANC) of 1200 or better; platelet count of 100,000/mm3 or better; hemoglobin (Hgb) ≥ 9.0g/dL.
  • Hepatic criteria: bilirubin must be less than or equal to 1.7. SGOT, SGPT may be up to 2 x institutional upper limit of normal (ULN) but with the presence of liver metastasis the SGOT, SGPT may be up to 3 x institutional ULN.
  • Serum creatinine must be < 1.5 mg/dl x ULN
  • Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
  • Patients must have a multigated acquisition (MUGA) scan or 2-d echocardiogram indicating an ejection fraction of ≥ 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.

Exclusion Criteria:

  • Patients with concurrent severe medical problems unrelated to malignancy, which would limit full compliance to the study or expose the patient to extreme risk with decreased life expectancy, are ineligible.
  • Patients with previous or concomitant malignancy other than curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other primary cancer completely resected or treated within five years are ineligible. Exceptions are patients who have had tumors treated with no evidence of active disease who are felt by both the enrolling physician and the principal investigator (PI) to have a risk of relapse of less than 30%.
  • Pregnant or lactating women.
  • History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride (HCL) or the components of Doxil®.
  • History of cardiac disease with New York Heart Association Class III or greater, or clinical evidence of congestive heart failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00252889

United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Johnson & Johnson
Principal Investigator: Michael J. Guarino, M.D. Christiana Care Health Services

Publications of Results:
Masters GA, et. al., A Phase I Study of Pegylated Doxorubicin (DOX) and Weekly Topotecan (TOP) in Patients (pts) with Advanced Solid Tumors. ASCO Abstract, submitted 12/14/05.

Responsible Party: Dr Gregory Masters MD Principal investigator, Christiana Care Health Services Identifier: NCT00252889     History of Changes
Other Study ID Numbers: 24062
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by Christiana Care Health Services:
Metastatic cancer
Metastatic gastric and esophagus adenocarcinoma
Unresectable pancreatic cancer
Unresectable head and neck cancer
Cancer of undetermined primary

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Head and Neck Neoplasms
Esophageal Neoplasms
Small Cell Lung Carcinoma
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Esophageal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Liposomal doxorubicin
Topoisomerase I Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors