Lung DiseasesPhase 1NCT00249964
Combination Paclitaxel, Carboplatin and Temozolomide
A Phase 1 study testing Combination Treatment - Cohort 1, Combination Treatment - Cohort 2 and Combination Treatment - Cohort 3 in people with Lung Diseases and Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Cancer
- What is being tested?
- Combination Treatment - Cohort 1, Combination Treatment - Cohort 2 and Combination Treatment - Cohort 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Mar 2011
- Phase
- Phase 1
- 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
- Age greater than or equal to 18 years
- Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B)
- Laboratory values (performed within 14 days prior to study drug administration, inclusive).
- Absolute neutrophil count (ANC) >1500/mm3
- Platelet count >100,000/mm3
- Hemoglobin >10 g/dl or 100 g/l
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- BUN and serum creatinine <1.5 times upper limit of laboratory normal
- Total and direct bilirubin <1.5 times upper limit of laboratory normal
- SGOT and SGPT <3 times upper limit of laboratory normal
- Alkaline Phosphatase <3 times upper limit of laboratory normal
- A life expectancy of greater than 12 weeks
- Subjects must give written informed consent.
- Biopsy proven small cell lung cancer.
- CT of chest, abdomen, pelvis and MRI of head
- Patients with brain metastases should be asymptomatic to enter the study
Who cannot join
- No recovery from all active toxicities of prior therapies.
- Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
- Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
- Known HIV positivity or AIDS-related illness.
- Pregnant or nursing women.
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- Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
- Men who are not advised to use an effective method of contraception.
- Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination.
- Known hypersensitivity reaction to taxoid or platinum compound.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
About this study
Official title: Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.
The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.
Read the detailed description
The objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).
- Conditions
- Lung Diseases, Cancer
- Being tested
- Combination Treatment - Cohort 1, Combination Treatment - Cohort 2, Combination Treatment - Cohort 3, Combination Treatment - Cohort 4
- Keywords
- Extensive or recurrent small cell lung cancer Phase I, Paclitaxel, Carboplatin, Temozolomide
- Medical subject headings
- Lung Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Treatment - Cohort 1Drug
Also called Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 75 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 2Drug
Also called Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 100 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 3Drug
Also called Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 125 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 4Drug
Also called Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 150 mg/m2 per day from day 2 to day 6.
| Study group | Role | What they receive |
|---|---|---|
| Combination Treatment | Experimental | Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days).
Cycle length is 21 days. Receives: Drug: Combination Treatment - Cohort 1; Drug: Combination Treatment - Cohort 2; Drug: Combination Treatment - Cohort 3; Drug: Combination Treatment - Cohort 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin
Temozolomide was administered at different dose levels (see Cohorts 1-4) until the maximum tolerated dose (MTD) was reached. MTD is the dose at which 0/6 or 1/6 patients in the cohort experience dose limiting toxicity (DLT) during the first 4 week cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will have occurred when the patient has 1 or more Grade 4 hematologic or nonhematologic toxicities. A DLT must occur in the first cycle of the combination and must be at least possibly attributed to the treatment regimen. Toxicities will be graded according to the NCI CTCAE Version 3.0.
Measured: 4 months
Secondary outcomes (1)
Tumor response rate
Tumor response is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 as determined by the investigator. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startNov 2003
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fa-Chyi Lee, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249964
- Sponsor's protocol ID
- 0100C
- Status last verified
- Jan 2016
- First submitted
- 3 Nov 2005
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.
- ClinicalTrials.gov ID
- NCT00249964
- Acronym / sponsor ID
- 0100C
- Conditions
- Lung Diseases, Cancer
- Keywords
- Extensive or recurrent small cell lung cancer Phase I, Paclitaxel, Carboplatin, Temozolomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Nov 2005 (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.
The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.
Detailed description
The objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Treatment | Experimental | Drug: Combination Treatment - Cohort 1, Drug: Combination Treatment - Cohort 2, Drug: Combination Treatment - Cohort 3, Drug: Combination Treatment - Cohort 4Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days). Cycle length is 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age greater than or equal to 18 years
- Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B)
- Laboratory values (performed within 14 days prior to study drug administration, inclusive).
- A life expectancy of greater than 12 weeks
- Subjects must give written informed consent.
Key exclusion criteria (10 listed)
- No recovery from all active toxicities of prior therapies.
- Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
- Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
- Known HIV positivity or AIDS-related illness.
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 |
|---|---|---|
| Combination Treatment - Cohort 1Also: Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 75 mg/m2 per day from day 2 to day 6. | Drug | Combination Treatment |
| Combination Treatment - Cohort 2Also: Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 100 mg/m2 per day from day 2 to day 6. | Drug | Combination Treatment |
| Combination Treatment - Cohort 3Also: Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 125 mg/m2 per day from day 2 to day 6. | Drug | Combination Treatment |
| Combination Treatment - Cohort 4Also: Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 150 mg/m2 per day from day 2 to day 6. | Drug | Combination Treatment |
Primary outcome
Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin
Time frame: 4 months
Temozolomide was administered at different dose levels (see Cohorts 1-4) until the maximum tolerated dose (MTD) was reached. MTD is the dose at which 0/6 or 1/6 patients in the cohort experience dose limiting toxicity (DLT) during the first 4 week cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will have occurred when the patient has 1 or more Grade 4 hematologic or nonhematologic toxicities. A DLT must occur in the first cycle of the combination and must be at least possibly attributed to the treatment regimen. Toxicities will be graded according to the NCI CTCAE Version 3.0.
1 secondary outcome
Tumor response rate
Time frame: 7 months
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 20 Jan 2016.
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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.
Fa-Chyi Lee, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination Treatment - Cohort 1, Combination Treatment - Cohort 2 and Combination Treatment - Cohort 3 in people with Lung Diseases and Cancer, run by New Mexico Cancer Research Alliance at 1 site 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 15 inclusion and 10 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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.
What does the primary outcome measure?
Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin (time frame: 4 months). 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 20 Jan 2016.