Unspecified Adult Solid Tumor, Protocol SpecificPhase 1/2NCT00004979
Topotecan and Paclitaxel in Treating Patients With Advanced Non-small Cell Lung Cancer or Other Advanced Solid Tumors
A Phase 1/2 study testing paclitaxel and topotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Jonsson Comprehensive Cancer Center.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining topotecan and paclitaxel in treating patients who have advanced non-small… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- paclitaxel and topotecan hydrochloride
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2000
- 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
DISEASE CHARACTERISTICS: Phase I: Advanced solid tumors, including non-small cell lung cancer (NSCLC), that have failed conventional therapy or for which no standard effective therapy exists May have failed conventional chemotherapy for tumor type Chemotherapy naive NSCLC allowed Measurable or evaluable disease Phase II: Stage IIIB or IV NSCLC not amenable to surgery or radiotherapy with curative intent No prior chemotherapy allowed At least 1 bidimensionally measurable non-CNS indicator lesion defined by diagnostic studies Measurable disease on CT or MRI scan must have one diameter at least 1 cm and one diameter at least 2 cm Measurable disease on chest x-ray must have both diameters at least 2 cm Palpable tumor masses that cannot be evaluated radiologically must have two diameters at least 2 cm Measurable skin lesion must have at least one diameter at least 1 cm and its presence must be evaluated by a photograph At least 6 weeks since prior radiotherapy to measurable, progressive disease No brain and/or leptomeningeal metastases by CT or MRI brain scan unless asymptomatic on neurologic exam and not receiving corticosteroid therapy to control symptoms
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 1.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 1.5 times ULN (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to and during study Able to take oral medication No active infection No other prior or concurrent malignancies except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No other severe medical problem unrelated to malignancy that would preclude study compliance or expose patient to extreme risk No condition of the gastrointestinal (GI) tract or otherwise that would affect GI absorption and motility No history of hypersensitivity reactions to paclitaxel or other drugs formulated in polyoxyethylated castor oil
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since palliative radiotherapy and recovered No prior radiotherapy to greater than 30% of bone marrow reserve No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery (lesser period acceptable if deemed in best interest of patient) Other: No concurrent metoclopramide or cisapride to maintain motility or gastric emptying At least 30 days or 5 half-lives since other prior investigational drugs for treatment of cancer No other concurrent investigational medication
About this study
Official title: Phase I/II Study of Oral Topotecan and Intravenous Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (Phases I and II) and Other Advanced Solid Tumors (Phase I Only)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining topotecan and paclitaxel in treating patients who have advanced non-small cell lung cancer or other advanced solid tumors.
Read the detailed description
OBJECTIVES: Phase I: I. Determine the maximum tolerated dose (MTD) of oral topotecan combined with a fixed dose of paclitaxel in patients with advanced non-small lung cancer (NSCLC) and other advanced solid tumors. II. Determine the response rate of NSCLC patients treated at the MTD of oral topotecan combined with intravenous paclitaxel. III. Determine the dose limiting toxicities of this drug combination in this patient population. Phase II: IV. Determine the toxicities of this regimen at its MTD in patients with NSCLC. V. Determine time to response, response duration, survival, time to progression, and rate of stable disease of patients with NSCLC treated with this regimen at the MTD. VI. Assess changes in well-being of patients with NSCLC treated with this regimen at the MTD.
OUTLINE: This is a dose escalation study of topotecan. Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients with non-small cell lung cancer are accrued to receive treatment with topotecan and paclitaxel at the recommended phase II dose. Quality of life is assessed in the phase II portion of the study at baseline, before each treatment course, and at the end of the study. Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I dose escalation portion of this study. A total of 14-40 additional non-small cell lung cancer patients will be accrued to the phase II portion of this study.
- Being tested
- paclitaxel, topotecan hydrochloride
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2004 (estimated)
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert A. Figlin, MD, FACP, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004979
- Sponsor's protocol ID
- CDR0000067543
- Other IDs
- UCLA-9904034, SB-104864/250, NCI-G00-1676
- Status last verified
- Jan 2001
- First submitted
- 7 Mar 2000
- Last updated
- 6 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Oral Topotecan and Intravenous Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (Phases I and II) and Other Advanced Solid Tumors (Phase I Only)
- ClinicalTrials.gov ID
- NCT00004979
- Acronym / sponsor ID
- CDR0000067543
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study completion
- Sep 2000 (actual)
- First posted
- 4 Jun 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining topotecan and paclitaxel in treating patients who have advanced non-small cell lung cancer or other advanced solid tumors.
Detailed description
OBJECTIVES: Phase I: I. Determine the maximum tolerated dose (MTD) of oral topotecan combined with a fixed dose of paclitaxel in patients with advanced non-small lung cancer (NSCLC) and other advanced solid tumors. II. Determine the response rate of NSCLC patients treated at the MTD of oral topotecan combined with intravenous paclitaxel. III. Determine the dose limiting toxicities of this drug combination in this patient population. Phase II: IV. Determine the toxicities of this regimen at its MTD in patients with NSCLC. V. Determine time to response, response duration, survival, time to progression, and rate of stable disease of patients with NSCLC treated with this regimen at the MTD. VI. Assess changes in well-being of patients with NSCLC treated with this regimen at the MTD.
OUTLINE: This is a dose escalation study of topotecan. Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients with non-small cell lung cancer are accrued to receive treatment with topotecan and paclitaxel at the recommended phase II dose. Quality of life is assessed in the phase II portion of the study at baseline, before each treatment course, and at the end of the study. Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I dose escalation portion of this study. A total of 14-40 additional non-small cell lung cancer patients will be accrued to the phase II portion of this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | – |
| topotecan hydrochloride | 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 6 Jan 2014.
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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.
Robert A. Figlin, MD, FACP study chair
Jonsson Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing paclitaxel and topotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Jonsson Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 6 Jan 2014.