Adenocarcinoma of the PancreasPhase 2NCT00026104
Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
A Phase 2 study testing gemcitabine hydrochloride, paclitaxel and tipifarnib in people with Adenocarcinoma of the Pancreas and Stage II Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
- What is being tested?
- gemcitabine hydrochloride, paclitaxel and tipifarnib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Aug 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas
- Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed
- No metastases in major viscera
- No peritoneal seeding or ascites
- Biliary or gastroduodenal obstruction must have drainage before starting study therapy
- Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum)
Show all 24Show fewer
- Performance status - Zubrod 0-1
- Granulocyte count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
- ALT less than 3 times upper limit of normal
- Bilirubin less than 2.0 mg/dL
- Creatinine less than 3.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
- No significant infection or other medical condition that would preclude study
- No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer
- No other concurrent cytotoxic agents
- See Disease Characteristics
- No prior radiotherapy to the planned field
- No other concurrent radiotherapy
- See Disease Characteristics
- No other concurrent investigational agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer
Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer.
Read the detailed description
OBJECTIVES:
- Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib.
II. Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients.
III. Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients.
IV. Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the preceding 6 months (more than 10% vs 10% or less) and tumor dimension (at least 5 cm vs less than 5 cm). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
Arm II: Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days.
Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Being tested
- gemcitabine hydrochloride, paclitaxel, tipifarnib, radiation therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Given IV
paclitaxelDrug
Also called Anzatax, Asotax, TAX, Taxol
Given IV
tipifarnibDrug
Also called R115777, Zarnestra
Given orally
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (radiation therapy, paclitaxel, gemcitabine) | Experimental | Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm II (radiation therapy, tipifarnib) | Experimental | Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days. Receives: Drug: tipifarnib; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Calculated along with associated 95% confidence intervals.
Measured: 1 year
Secondary outcomes (3)
Frequency of patients developing unacceptable toxicity defined as grade 3 or higher gastrointestinal or pulmonary toxicity and/or discontinuation of treatment
Graded according to the CTCAE version 3.0.
Measured: Up to 5 years
Difference in overall survival between treatment regimens
Estimated with a 95% confidence interval.
Measured: 1 year
Progression-free survival
Calculated along with associated 95% confidence intervals.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2001
- Primary completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the PancreasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Tyvin Rich, Principal investigator, Radiation Therapy Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026104
- Sponsor's protocol ID
- NCI-2012-02423
- Other IDs
- RTOG-PA-0020, CDR0000068986, U10CA021661
- Status last verified
- Oct 2020
- First submitted
- 9 Nov 2001
- Last updated
- 30 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00026104
- Acronym / sponsor ID
- NCI-2012-02423
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- NRG Oncology
- Study start
- Nov 2001
- Primary completion
- Aug 2006 (actual)
- First posted
- 27 Jan 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.
Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer.
Detailed description
OBJECTIVES:
- Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib.
II. Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients.
III. Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients.
IV. Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the preceding 6 months (more than 10% vs 10% or less) and tumor dimension (at least 5 cm vs less than 5 cm). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
Arm II: Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days.
Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (radiation therapy, paclitaxel, gemcitabine) | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapyPatients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. |
| Arm II (radiation therapy, tipifarnib) | Experimental | Drug: tipifarnib, Radiation: radiation therapyPatients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas
- No metastases in major viscera
- No peritoneal seeding or ascites
- Biliary or gastroduodenal obstruction must have drainage before starting study therapy
- Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| gemcitabine hydrochlorideAlso: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, GemzarGiven IV | Drug | Arm I (radiation therapy, paclitaxel, gemcitabine) |
| paclitaxelAlso: Anzatax, Asotax, TAX, TaxolGiven IV | Drug | Arm I (radiation therapy, paclitaxel, gemcitabine) |
| tipifarnibAlso: R115777, ZarnestraGiven orally | Drug | Arm II (radiation therapy, tipifarnib) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Arm I (radiation therapy, paclitaxel, gemcitabine), Arm II (radiation therapy, tipifarnib) |
Primary outcome
Overall survival
Time frame: 1 year
Calculated along with associated 95% confidence intervals.
3 secondary outcomes
Frequency of patients developing unacceptable toxicity defined as grade 3 or higher gastrointestinal or pulmonary toxicity and/or discontinuation of treatment
Time frame: Up to 5 years
Difference in overall survival between treatment regimens
Time frame: 1 year
Progression-free survival
Time frame: 1 year
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 30 Oct 2020.
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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.
Tyvin Rich principal investigator
Radiation Therapy Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine hydrochloride, paclitaxel and tipifarnib in people with Adenocarcinoma of the Pancreas and Stage II Pancreatic Cancer, run by National Cancer Institute (NCI) 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 24 inclusion and 0 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 30 Oct 2020. 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 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.
What does the primary outcome measure?
Overall survival (time frame: 1 year). 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 30 Oct 2020.