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Completed

NCT Number: NCT00705874

Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma

This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rocky Mountain Cancer Centre, Denver, Colorado, United States

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About this study

This study will use a dose escalation design to determine the MTD of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated in cohorts of 3 patients and dose escalation can proceed in each treatment group independent of dose escalation in the other treatment groups. CGC-11047 will be administered IV over 60 minutes and the doses of gemcitabine, docetaxel, bevacizumab, cisplatin, 5-flurouracil or sunitinib will remain fixed according to their respective product labeling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted.
  • measurable disease based on radiographic evaluation or elevated tumor markers.
  • ECOG - 0 or 1 (KPS >70).
  • Life expectancy > 3 months.

Exclusion criteria

  • chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study
  • known active brain metastases or leptomeningeal carcinomatosis.
  • history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias
  • clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.

Treatment and study plan

CGC-11047 and gemcitabine

Drug

Gemcitabine: (Closed to enrollment) 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle. CGC-11047 will only be given on days 1 and 15 of each cycle and will start at dose level -1 (50 mg).

Other names: Gemzar

CGC-11047 and docetaxel

Drug

Docetaxel: (Closed to enrollment) 75 mg/m2 administered IV over 60 minutes every 21 days. CGC-11047 will be administered only on Day 1 of each 21-day cycle and will start at dose level -1 (50 mg).

Other names: Taxotere

CGC-11047 and bevacizumab

Drug

Bevacizumab: 5 mg/kg administered IV once every 14 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.

Other names: Avastin

CGC-11047 and erlotinib

Drug

Erlotinib: 150 mg taken orally every day of each 28-day cycle. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.

Other names: Tarceva

CGC-11047 and cisplatin

Drug

Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.

CGC-11047 and 5-flurouracil / leucovorin

Drug

5-Flurouracil / Leucovorin: Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 wks, repeated every 56 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.

Other names: 5-FU, Florouracil, Efudix

CGC-11047 and sunitinib

Drug

Sunitinib: 50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle). CGC-11047 will be administered on Days 1 and 8 of a 21 day cycle.

Other names: Sutent

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: End of Study

    The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).

    DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:

    • Any nonhematologic toxicity > Grade 3 lasting > 3 days
    • Grade 4 thrombocytopenia
    • Grade 4 Anemia on the next scheduled dosing day
    • Grade 4 Neutropenia (lasting > than 5 days
    • Any febrile neutropenia (Grade 3 or 4))
    • Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity

Secondary outcomes

  1. Drug Safety

    Time frame: Ongoing

  2. Pharmacokinetics

    Time frame: End of Study

Sponsors and collaborators

Lead sponsor

Progen Pharmaceuticals

Industry

Registry information

Official study title

A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jun 26, 2008
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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