CancerPhase 1NCT00705874
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
A Phase 1 study testing CGC-11047 and gemcitabine, CGC-11047 and docetaxel and CGC-11047 and bevacizumab in people with Cancer, run by Progen Pharmaceuticals at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CGC-11047 and gemcitabine, CGC-11047 and docetaxel and CGC-11047 and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2006to Sep 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
New York Oncology Hematology PC
Albany, New York, 12206
Texas Oncology, PA
Dallas, Texas, 75246
Rocky Mountain Cancer Centre
Denver, Colorado
Cancer Centres of the Carolinas
Greenville, South Carolina, 29605
Central Indiana Cancer Centres
Indianapolis, Indiana, 46219
Dayton Oncology and Hematology, PA
Kettering, Ohio, 45409
Comprehensive Cancer Centres of Nevada
Las Vegas, Nevada, 89169
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Centres of Florida
Ocoee, Florida, 34761
Tyler Cancer Centre
Tyler, Texas, 75702
Northwest Cancer Specialists - Vancouver Cancer Centre
Vancouver, Washington, 98684
North Star Lodge Cancer Centre
Yakima, Washington, 98902
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- CGC-11047 and gemcitabine, CGC-11047 and docetaxel, CGC-11047 and bevacizumab, CGC-11047 and erlotinib, CGC-11047 and cisplatin
- Keywords
- cancer, advanced cancer, solid tumors, lymphoma, CGC-11047
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGC-11047 and gemcitabineDrug
Also called Gemzar
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).
CGC-11047 and docetaxelDrug
Also called Taxotere
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).
CGC-11047 and bevacizumabDrug
Also called Avastin
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.
CGC-11047 and erlotinibDrug
Also called Tarceva
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.
CGC-11047 and cisplatinDrug
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 / leucovorinDrug
Also called 5-FU, Florouracil, Efudix
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.
CGC-11047 and sunitinibDrug
Also called Sutent
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CGC-11047 in combination with Gemcitabine Receives: Drug: CGC-11047 and gemcitabine |
| 2 | Experimental | CGC-11047 in combination with Docetaxel Receives: Drug: CGC-11047 and docetaxel |
| 3 | Experimental | CGC-11047 in combination with Bevacizumab Receives: Drug: CGC-11047 and bevacizumab |
| 4 | Experimental | CGC-11047 in combination with Erlotinib Receives: Drug: CGC-11047 and erlotinib |
| 5 | Experimental | 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. Receives: Drug: CGC-11047 and cisplatin |
| 6 | Experimental | CGC-11047 in combination with 5-Flurouracil / Leucovorin Receives: Drug: CGC-11047 and 5-flurouracil / leucovorin |
| 7 | Experimental | CGC-11047 in combination with Sunitinib Receives: Drug: CGC-11047 and sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
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
Measured: End of Study
Secondary outcomes (2)
Drug Safety
Measured: Ongoing
Pharmacokinetics
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startMay 2006
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Stephenson, MD, Principal investigator, Cancer Centres of the Carolinas, Greenville, SC 29605
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705874
- Sponsor's protocol ID
- 47-01-002
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2008
- Last updated
- 21 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00705874
- Acronym / sponsor ID
- 47-01-002
- Conditions
- Cancer
- Keywords
- cancer, advanced cancer, solid tumors, lymphoma, CGC-11047
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Progen PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 27 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CGC-11047 and gemcitabineCGC-11047 in combination with Gemcitabine |
| 2 | Experimental | Drug: CGC-11047 and docetaxelCGC-11047 in combination with Docetaxel |
| 3 | Experimental | Drug: CGC-11047 and bevacizumabCGC-11047 in combination with Bevacizumab |
| 4 | Experimental | Drug: CGC-11047 and erlotinibCGC-11047 in combination with Erlotinib |
| 5 | Experimental | Drug: CGC-11047 and cisplatinCisplatin: 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. |
| 6 | Experimental | Drug: CGC-11047 and 5-flurouracil / leucovorinCGC-11047 in combination with 5-Flurouracil / Leucovorin |
| 7 | Experimental | Drug: CGC-11047 and sunitinibCGC-11047 in combination with Sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGC-11047 and gemcitabineAlso: GemzarGemcitabine: (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). | Drug | 1 |
| CGC-11047 and docetaxelAlso: TaxotereDocetaxel: (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). | Drug | 2 |
| CGC-11047 and bevacizumabAlso: AvastinBevacizumab: 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. | Drug | 3 |
| CGC-11047 and erlotinibAlso: TarcevaErlotinib: 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. | Drug | 4 |
| CGC-11047 and cisplatinCisplatin: 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. | Drug | 5 |
| CGC-11047 and 5-flurouracil / leucovorinAlso: 5-FU, Florouracil, Efudix5-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. | Drug | 6 |
| CGC-11047 and sunitinibAlso: SutentSunitinib: 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. | Drug | 7 |
Primary outcome
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: 1. Any nonhematologic toxicity > Grade 3 lasting > 3 days 2. Grade 4 thrombocytopenia 3. Grade 4 Anemia on the next scheduled dosing day 4. Grade 4 Neutropenia (lasting > than 5 days 5. Any febrile neutropenia (Grade 3 or 4)) 6. Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity
2 secondary outcomes
Drug Safety
Time frame: Ongoing
Pharmacokinetics
Time frame: End of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Progen Pharmaceuticals websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Stephenson, MD principal investigator
Cancer Centres of the Carolinas, Greenville, SC 29605
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CGC-11047 and gemcitabine, CGC-11047 and docetaxel and CGC-11047 and bevacizumab in people with Cancer, run by Progen Pharmaceuticals at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.