CancerPhase 1NCT00005842
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer
A Phase 1 study testing trastuzumab and tipifarnib in people with Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- trastuzumab and tipifarnib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2000to Feb 2004
- 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 advanced or metastatic adenocarcinoma
- Expression of +1 to 3+ HER2/neu on immunohistochemical or immunocytochemistry staining
- No brain metastases unless all of the following is true:
- Previously treated
- Asymptomatic
- Stable dose of decadron
- No evidence of edema
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: ECOG 0-2
- Life expectancy: At least 12 weeks
- Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9.0 g/dL
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver involvement)
- Creatinine no greater than 1.5 mg/dL
- LVEF at least 50% by RVG or MUGA
- No uncontrolled unstable angina
- No history of congestive heart failure or cardiac ischemia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent active infection or serious systemic disorder that would preclude study
- No allergies to imidazole compounds
PRIOR CONCURRENT THERAPY:
- No prior trastuzumab (Herceptin) No other concurrent immunotherapy
- At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered
- No other concurrent chemotherapy
- No concurrent hormonal cancer therapy except LHRH agonists for prostate cancer
- No concurrent radiotherapy
- No other concurrent experimental medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Institute for Drug Development
San Antonio, Texas, 78245-3217
About this study
Official title: A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer
Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.
II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.
III. Determine the antitumor activity of this treatment regimen in these patients.
IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients.
OUTLINE: This is a dose escalation, multicenter study of R115777.
Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.
Patients are followed every 30 days until toxicity resolves.
- Conditions
- Cancer
- Being tested
- trastuzumab, tipifarnib
- Keywords
- stage III colon cancer, stage IV colon cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, occult non-small cell lung cancer, stage IIIB breast cancer, recurrent non-small cell lung cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV anal cancer, recurrent anal cancer, stage III esophageal cancer
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Breast Neoplasms, Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Rectal Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
tipifarnibDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities. Receives: Biological: trastuzumab; Drug: tipifarnib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2004 (estimated)
- Study startJun 2000
- Primary completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anthony W. Tolcher, MD, Study chair, San Antonio Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005842
- Sponsor's protocol ID
- CDR0000067858
- Other IDs
- UTHSC-IDD-99-26, SACI-IDD-99-26, NCI-62
- Status last verified
- Apr 2007
- First submitted
- 2 Jun 2000
- Last updated
- 11 Feb 2013
- Results posted
- No
Publications
Schwartz G, Rowinsky EK, Rha SY, et al.: A phase I, pharmacokinetic, and biologic correlative study of R115777 and trastuzumab (herceptin) in patients with advanced cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-322, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00005842
- Acronym / sponsor ID
- CDR0000067858
- Conditions
- Cancer
- Keywords
- stage III colon cancer, stage IV colon cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2000
- Primary completion
- Feb 2004 (actual)
- First posted
- 26 Apr 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.
Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.
II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.
III. Determine the antitumor activity of this treatment regimen in these patients.
IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients.
OUTLINE: This is a dose escalation, multicenter study of R115777.
Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.
Patients are followed every 30 days until toxicity resolves.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: trastuzumab, Drug: tipifarnibPatients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities. |
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 |
|---|---|---|
| trastuzumab | Biological | Arm I |
| tipifarnib | Drug | Arm I |
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 11 Feb 2013.
- Results publicationSchwartz G, Rowinsky EK, Rha SY, et al.: A phase I, pharmacokinetic, and biologic correlative study of R115777 and trastuzumab (herceptin) in patients with advanced cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-322, 2001.
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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.
Anthony W. Tolcher, MD study chair
San Antonio Cancer Institute
2 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 trastuzumab and tipifarnib in people with Cancer, run by National Cancer Institute (NCI) at 2 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
On the ClinicalTrials.gov record for NCT00005842, which also lists 1 linked publication.
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 11 Feb 2013.