Stage IIIB Non-Small Cell Lung CancerPhase 1/2NCT00088088
STA-4783 in Combination With Paclitaxel and Carboplatin for the Treatment of Chemotherapy Naive Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing Paclitaxel, Carboplatin and STA 4783 in people with Stage IIIB Non-Small Cell Lung Cancer and Stage IV Non-Small Cell Lung Cancer, run by Synta Pharmaceuticals Corp. at 19 sites in United States.
Trial summary
This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had chemotherapy before for their disease. The first phase of the study recently completed and for the second phase of the study patients are randomly assigned to receive either paclitaxel and carboplatin or paclitaxel and carboplatin and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- What is being tested?
- Paclitaxel, Carboplatin and STA 4783
- How many people
- 86 participants
- Where
- 19 sitesUnited States
- Study dates
- Mar 2004to Mar 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Histologically and/or cytologically proven NSCLC (mixed forms with small cell lung cancer are excluded) with clinically stage IIIB or stage IV disease.
- No prior systemic chemotherapy treatment.
- Prior treatments with radiotherapy or local ablative therapies are allowed if these therapies do not affect the measurable target lesions being used for the purposes of this protocol. Completion of any radiotherapy must be greater than or equal to 4 weeks prior to study entry, and/or resolution of all acute toxic effects of any prior radiotherapy or major surgical procedure to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade less than or equal to 1.
- Evidence of unidimensionally measurable disease (ie, greater than or equal to 1 malignant tumor mass that may be accurately measured in at least 1 dimension greater than or equal to 20 mm with conventional radiographic techniques or magnetic resonance imaging [MRI], or greater than or equal to 10 mm with spiral computerized tomography [CT] scan). Tumor evaluation by positron emission tomography (PET) scan or by ultrasound may not substitute for CT or MRI scans. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions, and disease documented by indirect evidence only (eg, by laboratory tests such as alkaline phosphatase) are not considered measurable.
- Female or male, 18 years of age or older.
- ECOG performance status 0 or 1.
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- Neuropathy of Grade 0 or Grade 1.
- Adequate organ function as defined by the following criteria:
- Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase) [SGPT] less than or equal to 2.5 x central laboratory upper limit of normal (ULN). If liver function abnormalities are due to underlying malignancy, then AST and ALT may be less than or equal to 5 x ULN.
- Total serum bilirubin less than or equal to 1.5 x ULN
- Prothrombin time (PT) and partial thromboplastin time (PTT) less than or equal to 1.5x ULN
- Absolute neutrophil count (ANC) greater than or equal to 1500/mL
- Platelets greater than or equal to 100,000/mL
- Hemoglobin greater than or equal to 9.0 g/dL
- Serum creatinine less than or equal to 1.5 x ULN
- The effects of STA-4783 on the developing human fetus are unknown, however, taxanes and platinum analogues are known to be teratogenic. Therefore, women of childbearing potential (defined as, unless surgically sterile, women <=50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she must agree to inform the treating physician immediately, and be followed until delivery.
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Patients with large untreated pleural effusions, or who have immediate life-threatening complications of their disease, or those who may need urgent radiotherapy (e.g., due to lobar obstruction, painful bony sites, cord compression, or superior vena cava syndrome).
- Current participation in another clinical drug trial; may not be receiving an investigational drug or any other agent that has an immunomodulatory or presumed anti-tumor effect within 4 weeks of study entry.
- Known brain metastases, or leptomeningeal disease on screening CT or MRI scan, except for treated disease that is considered clinically and radiologically stable, and does not require treatment with anti-convulsants and/or steroids.
- Prior malignancy other than NSCLC within the last 5 years with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri;
- Basal or squamous cell carcinoma of the skin;
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- Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.
- Has a known allergy to Cremophor® or Cremophor®-based drug products.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Pregnancy or breast feeding.
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Maryland Hematology and Oncology Associates
Baltimore, Maryland, 21236
University of Chicago
Chicago, Illinois, 60637
Presbyterian Hospital
Dallas, Texas, 75231
The Duluth Clinic
Duluth, Minnesota, 55805
The Cancer Institute at Alexian Brothers
Elk Grove Village, Illinois, 60007
Ingalls Hospital
Harvey, Illinois, 60426
NEA Clinic
Jonesboro, Arkansas, 72401
The West Clinic
Memphis, Tennessee, 38120
ACORN
Miami, Florida
The Sarah Cannon Research Center
Nashville, Tennessee, 37203
Wilshire Oncology Medical Group
Pomona, California, 91767
St. Francis Memorial Hospital
San Francisco, California
Cancer Institute Medical Group
Santa Monica, California, 90404
Oncology Hematology Consultants
Sarasota, Florida, 34236
Overton Brooks, VAMC
Shreveport, Louisiana, 71101
LSUHSC - Shreveport Feist Weiller Cancer Center
Shreveport, Louisiana, 71130
Multicare Health System
Tacoma, Washington, 98405
Oncology Associates of Bridgeport
Trumball, Connecticut, 06611
Kaiser Permanete
Vallejo, California
About this study
Official title: A Phase I/II Trial of STA-4783 in Combination With Paclitaxel and Carboplatin for the Treatment of Chemotherapy Naive Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had chemotherapy before for their disease. The first phase of the study recently completed and for the second phase of the study patients are randomly assigned to receive either paclitaxel and carboplatin or paclitaxel and carboplatin and study drug (STA 4783). Treatment will be every 3 weeks for 6 cycles.
- Being tested
- Paclitaxel, Carboplatin, STA 4783
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
CarboplatinDrug
STA 4783Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2004 (estimated)
- Study startMar 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB Non-Small Cell Lung 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088088
- Sponsor's protocol ID
- 4783-02
- Status last verified
- Dec 2008
- First submitted
- 20 Jul 2004
- Last updated
- 4 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of STA-4783 in Combination With Paclitaxel and Carboplatin for the Treatment of Chemotherapy Naive Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00088088
- Acronym / sponsor ID
- 4783-02
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Mar 2005
- First posted
- 21 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had chemotherapy before for their disease. The first phase of the study recently completed and for the second phase of the study patients are randomly assigned to receive either paclitaxel and carboplatin or paclitaxel and carboplatin and study drug (STA 4783). Treatment will be every 3 weeks for 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically and/or cytologically proven NSCLC (mixed forms with small cell lung cancer are excluded) with clinically stage IIIB or stage IV disease.
- No prior systemic chemotherapy treatment.
- Prior treatments with radiotherapy or local ablative therapies are allowed if these therapies do not affect the measurable target lesions being used for the purposes of this protocol. Completion of any radiotherapy must be greater than or equal to 4 weeks prior to study entry, and/or resolution of all acute toxic effects of any prior radiotherapy or major surgical procedure to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade less than or equal to 1.
- Evidence of unidimensionally measurable disease (ie, greater than or equal to 1 malignant tumor mass that may be accurately measured in at least 1 dimension greater than or equal to 20 mm with conventional radiographic techniques or magnetic resonance imaging [MRI], or greater than or equal to 10 mm with spiral computerized tomography [CT] scan). Tumor evaluation by positron emission tomography (PET) scan or by ultrasound may not substitute for CT or MRI scans. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions, and disease documented by indirect evidence only (eg, by laboratory tests such as alkaline phosphatase) are not considered measurable.
- Female or male, 18 years of age or older.
Key exclusion criteria (11 listed)
- Patients with large untreated pleural effusions, or who have immediate life-threatening complications of their disease, or those who may need urgent radiotherapy (e.g., due to lobar obstruction, painful bony sites, cord compression, or superior vena cava syndrome).
- Current participation in another clinical drug trial; may not be receiving an investigational drug or any other agent that has an immunomodulatory or presumed anti-tumor effect within 4 weeks of study entry.
- Known brain metastases, or leptomeningeal disease on screening CT or MRI scan, except for treated disease that is considered clinically and radiologically stable, and does not require treatment with anti-convulsants and/or steroids.
- Prior malignancy other than NSCLC within the last 5 years with the exception of:
- Has a known allergy to Cremophor® or Cremophor®-based drug products.
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 |
|---|---|---|
| Paclitaxel | Drug | – |
| Carboplatin | Drug | – |
| STA 4783 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paclitaxel, Carboplatin and STA 4783 in people with Stage IIIB Non-Small Cell Lung Cancer and Stage IV Non-Small Cell Lung Cancer, run by Synta Pharmaceuticals Corp. at 19 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 18 inclusion and 11 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 4 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 4 Dec 2008.