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Doxil Topotecan Doublet Cancer Study

This study has been completed.
Johnson & Johnson
Information provided by:
Christiana Care Health Services Identifier:
First received: November 11, 2005
Last updated: January 26, 2009
Last verified: January 2009

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 Intervention Phase
Small Cell Lung Cancer
Pancreatic Cancer
Head and Neck Cancer
Gastric Cancer
Esophageal Cancer
Drug: Topotecan and pegylated doxorubicin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Parameters of response: tumor measurement: Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: every other cycle ]
  • 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 ]
  • 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 ]

Enrollment: 20
Study Start Date: May 2004
Study Completion Date: June 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: November 11, 2005
Last Updated: January 26, 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 processed this record on March 29, 2017