Esophageal CancerPhase 2NCT00006081
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
A Phase 2 study testing Bryostatin-1 and Paclitaxel (Taxol) in people with Esophageal Cancer and Gastric Cancer, run by M.D. Anderson Cancer Center at 2 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 II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Bryostatin-1 and Paclitaxel (Taxol)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2000to Sep 2005
- 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
Who may be able to join
- Patients with histologic proof of adenocarcinoma of the stomach or gastroesophageal junction will be eligible.
- Patients must have either metastatic or unresectable local-regional cancer
- Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
- Patients may not have received prior chemotherapy or immunotherapy regimen except in the adjuvant therapy that ended at least 6 months prior to registration on this study.
- Prior limited radiation therapy is permitted. Prior radiotherapy must not have included major bone marrow containing areas (pelvis, lumbar spine), or contained the single evaluable lesion in the radiation field. A recovery period of at least 4 weeks after completion of radiotherapy is required prior to enrollment. Patients receiving chemotherapy used as radiosensitizer will not be eligible except if chemoradiotherapy was administered in the adjuvant setting (see 4.4).
- Patients must have a life expectancy of at least 12 weeks.
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- Patients must have a performance status of less than or equal to 2 (Zubrod scale) or greater than or equal to 60% (Karnofsky scale) (see appendix B).
- Patients must give written informed consent.
- Acceptable liver, renal, and marrow function
- Patients must be be at least 18 years old.
- Patients must have recovered from recent surgery. One week must have elapsed from the time of a minor surgery and 3 weeks from major surgery.
- This clinical trial is so designed that no person shall on the grounds of race, color, gender or national origin be excluded from participation in or be denied the benefits, or be otherwise subjected to discrimination through or under this study.
Who cannot join
- Patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy.
- Patients with brain metastases are not eligible.
- Patients with NYHA Class III or IV heart disease are not eligible (see Appendix F) as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
- Pregnant or lactating women because paclitaxel and bryostatin-1, like most other anticancer agents, may be harmful to the developing fetus and nursing newborn or infant. All women of child-bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child-bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
- Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, are ineligible.
- Patients with psychiatric disorders rendering them incapable of complying wiht the requirements of the protocol are ineligible.
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- Patients with serum calcium greater > 12 mg/dl or symptomatic hypercalcemia under treatment are ineligible.
- Patients with only bone metastases.
- Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence for greater than or equal to 5 years will be allowed to enter the trial.
- Patients wit bleeding diathesis or those requiring anticoagulation will be excluded.
- Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
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 II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel.
- Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Bryostatin-1, Paclitaxel (Taxol)
- Keywords
- stage III gastric cancer, stage IV gastric cancer, stage III esophageal cancer, stage IV esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bryostatin-1Drug
40 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16).
Paclitaxel (Taxol)Drug
Also called Taxol
80 mg/m^2 one-hour infusion weekly x 3 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bryostatin-1 + Taxol | Experimental | Not described Receives: Drug: Bryostatin-1; Drug: Paclitaxel (Taxol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Response after 2 Cycles of Treatment
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2003 (estimated)
- Study startJun 2000
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jaffer A. Ajani, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006081
- Sponsor's protocol ID
- ID99-203
- Other IDs
- U01CA070172, P30CA016672, MDA-ID-99203, NCI-T99-0103, CDR0000068069
- Status last verified
- Jul 2012
- First submitted
- 3 Aug 2000
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT00006081
- Acronym / sponsor ID
- ID99-203
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- stage III gastric cancer, stage IV gastric cancer, stage III esophageal cancer, stage IV esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2000
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 25 Jul 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 II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel.
- Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bryostatin-1 + Taxol | Experimental | Drug: Bryostatin-1, Drug: Paclitaxel (Taxol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with histologic proof of adenocarcinoma of the stomach or gastroesophageal junction will be eligible.
- Patients must have either metastatic or unresectable local-regional cancer
- Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
- Patients may not have received prior chemotherapy or immunotherapy regimen except in the adjuvant therapy that ended at least 6 months prior to registration on this study.
- Prior limited radiation therapy is permitted. Prior radiotherapy must not have included major bone marrow containing areas (pelvis, lumbar spine), or contained the single evaluable lesion in the radiation field. A recovery period of at least 4 weeks after completion of radiotherapy is required prior to enrollment. Patients receiving chemotherapy used as radiosensitizer will not be eligible except if chemoradiotherapy was administered in the adjuvant setting (see 4.4).
Key exclusion criteria (11 listed)
- Patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy.
- Patients with brain metastases are not eligible.
- Patients with NYHA Class III or IV heart disease are not eligible (see Appendix F) as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
- Pregnant or lactating women because paclitaxel and bryostatin-1, like most other anticancer agents, may be harmful to the developing fetus and nursing newborn or infant. All women of child-bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child-bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
- Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, are ineligible.
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 |
|---|---|---|
| Bryostatin-140 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16). | Drug | Bryostatin-1 + Taxol |
| Paclitaxel (Taxol)Also: Taxol80 mg/m^2 one-hour infusion weekly x 3 every 4 weeks | Drug | Bryostatin-1 + Taxol |
Primary outcome
Number of Patients with Response after 2 Cycles of Treatment
Time frame: 8 Weeks
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 Jul 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Jaffer A. Ajani, MD study chair
M.D. Anderson Cancer Center
2 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 Bryostatin-1 and Paclitaxel (Taxol) in people with Esophageal Cancer and Gastric Cancer, run by M.D. Anderson Cancer Center 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?
The sponsor lists 12 inclusion and 11 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 Jul 2012. 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 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?
Number of Patients with Response after 2 Cycles of Treatment (time frame: 8 Weeks). 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 Jul 2012.