Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00004243
Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
A Phase 1 study testing docetaxel and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 3 sites in United States.
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 trial to study the effectiveness of docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid… 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?
- docetaxel and oxaliplatin
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Mar 2000to not given
- 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
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists No known brain metastases or carcinomatosis meningitis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 OR Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of neuropathy No history of allergy to platinum compounds No history of allergy to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No uncontrolled concurrent illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude consent and follow up
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: Prior chemotherapy, including fluorouracil and cisplatin, allowed At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: At least 30 days since other prior investigational drugs No other concurrent investigational or commercial agents or therapies No concurrent antiretroviral therapy (HAART)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: A Phase I Study of Oxaliplatin in Combination With Docetaxel (Taxotere) Metastatic/Recurrent Solid Tumors
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 trial to study the effectiveness of docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when followed by oxaliplatin in patients with metastatic or recurrent solid tumors. II. Describe the toxicities of this regimen in this patient population at each dose level studied. III. Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed for disease progression.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 2 years.
- Being tested
- docetaxel, oxaliplatin
- 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.
docetaxelDrug
oxaliplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2003 (estimated)
- Study startMar 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 City of Hope Medical 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
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Heinz-Josef Lenz, MD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004243
- Sponsor's protocol ID
- CDR0000067488
- Other IDs
- U01CA062505, CHNMC-PHASEI-24, CHNMC-IRB-99081, LAC-USC-OC-99-2, NCI-T99-0004
- Status last verified
- Jan 2010
- First submitted
- 28 Jan 2000
- Last updated
- 13 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Oxaliplatin in Combination With Docetaxel (Taxotere) Metastatic/Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT00004243
- Acronym / sponsor ID
- CDR0000067488
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2000
- First posted
- 18 Apr 2003 (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 trial to study the effectiveness of docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when followed by oxaliplatin in patients with metastatic or recurrent solid tumors. II. Describe the toxicities of this regimen in this patient population at each dose level studied. III. Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed for disease progression.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 2 years.
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 |
|---|---|---|
| docetaxel | Drug | – |
| oxaliplatin | 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 13 Jan 2010.
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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.
Heinz-Josef Lenz, MD study chair
University of Southern California
3 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 docetaxel and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 3 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?
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 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 13 Jan 2010.