Lung CancerPhase 2NCT00003072
Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer
A Phase 2 study testing amifostine trihydrate, carboplatin and paclitaxel in people with Lung Cancer and Neurotoxicity, run by University of California, San Francisco at 4 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 and giving the drugs in different combinations may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Neurotoxicity, Ovarian Cancer
- What is being tested?
- amifostine trihydrate, carboplatin and paclitaxel
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- May 1997to Oct 1998
- Phase
- Phase 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: Histologically proven stage III/IV ovarian or non-small cell lung cancer
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing No history of platinum, paclitaxel or amifostine hypersensitivity Prior myelosuppressive events allowed No clinically significant ascites
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 1 month of study Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy within 1 month of study Surgery: Not specified
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Oncology Service of San Francisco General Hospital Medical Center
San Francisco, California, 94110
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
UCSF/Mt. Zion Cancer Center
San Francisco, California, 94115
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
About this study
Official title: Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial
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 and giving the drugs in different combinations may kill more tumor cells.
PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Determine whether patients with metastatic ovarian and non-small cell lung cancer receiving carboplatin and paclitaxel have significantly fewer neuropathic events when treated with amifostine.
OUTLINE: This is a randomized, parallel group, double blind, controlled study. Patients are randomized to either the amifostine or control group. All patients receive intravenous paclitaxel over 3 hours, followed by carboplatin once every 3 weeks for 6 cycles. Patients who are randomized to the amifostine group receive intravenous amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel therapy. Patients randomized to the control group receive an intravenous placebo solution. Patients are discontinued from the study if they have disease progression or unacceptable toxic effects after 2 cycles of treatment. Patients are followed monthly for 8 months post treatment.
PROJECTED ACCRUAL: A total of 80 patients will be accrued (40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer) within 2 years.
- Conditions
- Lung Cancer, Neurotoxicity, Ovarian Cancer
- Being tested
- amifostine trihydrate, carboplatin, paclitaxel
- Keywords
- stage III non-small cell lung cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IV non-small cell lung cancer, neurotoxicity
- Medical subject headings
- Lung Neoplasms, Neurotoxicity Syndromes, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amifostine trihydrateDrug
carboplatinDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2004 (estimated)
- Study startMay 1997
- Primary completionOct 1998
- Study completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2
- Primary purpose
- Supportive care
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Robert J. Ignoffo, PharmD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003072
- Sponsor's protocol ID
- CDR0000065752
- Other IDs
- UCSF-H57841348101A, ALZA-UCSF-H57841348101A, NCI-V97-1334
- Status last verified
- Sep 2012
- First submitted
- 1 Nov 1999
- Last updated
- 21 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial
- ClinicalTrials.gov ID
- NCT00003072
- Acronym / sponsor ID
- CDR0000065752
- Conditions
- Lung Cancer, Neurotoxicity, Ovarian Cancer
- Keywords
- stage III non-small cell lung cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IV non-small cell lung cancer, neurotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 1997
- Primary completion
- Oct 1998 (actual)
- Study completion
- Oct 1998 (actual)
- First posted
- 6 Sep 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 and giving the drugs in different combinations may kill more tumor cells.
PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine whether patients with metastatic ovarian and non-small cell lung cancer receiving carboplatin and paclitaxel have significantly fewer neuropathic events when treated with amifostine.
OUTLINE: This is a randomized, parallel group, double blind, controlled study. Patients are randomized to either the amifostine or control group. All patients receive intravenous paclitaxel over 3 hours, followed by carboplatin once every 3 weeks for 6 cycles. Patients who are randomized to the amifostine group receive intravenous amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel therapy. Patients randomized to the control group receive an intravenous placebo solution. Patients are discontinued from the study if they have disease progression or unacceptable toxic effects after 2 cycles of treatment. Patients are followed monthly for 8 months post treatment.
PROJECTED ACCRUAL: A total of 80 patients will be accrued (40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer) within 2 years.
Study design
- Primary purpose
- Supportive care
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 |
|---|---|---|
| amifostine trihydrate | Drug | – |
| carboplatin | Drug | – |
| paclitaxel | 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 21 Sep 2012.
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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 J. Ignoffo, PharmD study chair
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amifostine trihydrate, carboplatin and paclitaxel in people with Lung Cancer and Neurotoxicity, run by University of California, San Francisco at 4 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 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 21 Sep 2012.