Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer

NCT00006081 | Completed Phase 2

• 6 other identifiers: ID99-203U01CA070172P30CA016672MDA-ID-99203NCI-T99-0103CDR0000068069
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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 advanced or metastatic stomach cancer.

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Response after 2 Cycles of Treatment

  8 Weeks

Study Arms (1)

Bryostatin-1 + Taxol

EXPERIMENTAL

Drug: Bryostatin-1; Drug: Paclitaxel (Taxol)

Interventions

Bryostatin-1 DRUG

40 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16).

Bryostatin-1 + Taxol

Paclitaxel (Taxol) DRUG

80 mg/m\^2 one-hour infusion weekly x 3 every 4 weeks

Also known as: Taxol

Bryostatin-1 + Taxol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

CCOP - M.D. Anderson Research Base

Houston, Texas, 77030-4009, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Bryostatins; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Polyether Toxins; Polyether Polyketides; Ethers, Cyclic; Ethers; Organic Chemicals; Macrolides; Polyketides; Lactones; Macrocyclic Compounds; Polycyclic Compounds; Marine Toxins; Toxins, Biological; Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Jaffer A. Ajani, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: July 25, 2003
• Study Start: June 1, 2000
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (2)